Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 9:10 AM
Study NCT ID:
NCT05339334
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719967', 'term': 'nirmatrelvir and ritonavir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to Day 42.', 'description': 'The adverse events were reported by the treatment group of PF-07321332 300 mg + Ritonavir 100 mg, instead of by 2 treatment groups separately as PF-07321332 and ritonavir were dosed simultaneously (within no more than 5 minutes of each other).', 'eventGroups': [{'id': 'EG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 6, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '3082', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Cmax is maximum plasma concentration .', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '4500', 'spread': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Cmax is maximum plasma concentration', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '19660', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time Zero to time point on 12 hours', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '32010', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '2668', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by AUCtau/tau.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.627', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.461', 'spread': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Peak-to-trough Ratio (PTR) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.517', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by Day 10 Cmax/Day 10 Ctrough.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Apparent Clearance (CL/F) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.379', 'spread': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral clearance. This was determined by Dose/AUCtau.', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '91.01', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral volume of distribution.', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Terminal Elimination Half-life (t½) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.842', 'spread': '1.2336', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)', 'description': 'Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.', 'unitOfMeasure': 'Hours (hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '41460', 'spread': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Trough Concentration (Ctrough) on Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1389', 'spread': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 (pre-dose)', 'description': 'Concentration at pre-dose on Day 5. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Trough Concentration (Ctrough) on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1481', 'spread': '27', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8 (pre-dose)', 'description': 'Concentration at pre-dose on Day 8. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1333', 'spread': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose)', 'description': 'Concentration at pre-dose on Day 10. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'PRIMARY', 'title': 'PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '997.4', 'spread': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (12 hours after last dose)', 'description': 'Concentration at 12 hour time on Day 10. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to Day 42', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)', 'description': 'Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \\>= 30 mmHg, max. increase \\>=30 mmHg; diastolic BP min. \\<50mmHg; diastolic BP change from baseline max. decrease \\>=20, max. increase \\>=20; seated pulse rate min. \\<40 beats per minute (bpm) and max. \\>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'title': 'Urate (milligrams per decilitre[mg/dL]) > 1.2x upper limit of normal (ULN)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Fibrinogen (mg/dL) < 0.75x Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Fibrinogen (mg/dL) > 1.25x Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Urine Hemoglobin ≥ 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.', 'description': 'Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\\[msec\\]) \\>450 and ≤480, or \\>480 and ≤500, or \\>500; Increase from baseline in QTcF (msec) \\>30 and ≤60, or\\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \\>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants who took at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '545.8', 'spread': '50', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Cmax is maximum plasma concentration', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '1109', 'spread': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Cmax is maximum plasma concentration', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration', 'unitOfMeasure': 'hours (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '3136', 'spread': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '6152', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '7118', 'spread': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '512.9', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by AUCtau/tau.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Apparent Clearance (CL/F) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '16.25', 'spread': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral clearance. This was determined by Dose/AUCtau.', 'unitOfMeasure': 'Liter/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '123.0', 'spread': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral volume of distribution. This was determined by Dose/(AUCtau\\*kel)', 'unitOfMeasure': 'Liters (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Terminal Elimination Half-life (t½) on Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.471', 'spread': '1.7871', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)', 'description': 'Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.', 'unitOfMeasure': 'Hours (hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Trough Concentration (Ctrough) on Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '233.3', 'spread': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 (pre-dose)', 'description': 'Concentration at pre-dose on Day 5. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Trough Concentration (Ctrough) on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '212.8', 'spread': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8 (pre-dose)', 'description': 'Concentration at pre-dose on Day 8. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '200.8', 'spread': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (pre-dose)', 'description': 'Concentration at pre-dose on Day 10. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}, {'type': 'SECONDARY', 'title': 'Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'classes': [{'categories': [{'measurements': [{'value': '134.9', 'spread': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 10 (12 hours after last dose)', 'description': 'Concentration at 12 hour on Day 10. Observed directly from data.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis set was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The study consisted of 1 treatment group: multiple oral doses of PF-07321332300 mg/ritonavir 100 mg. A total of 14 healthy participants were enrolled and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-07321332 300 mg + Ritonavir 100 mg', 'description': 'The study interventions used in the study were PF-07321332 300 mg and ritonavir 100 mg, administered orally once every 12 hours (q12h) for a total of 19 doses (Day 1 to Day 10), with the last dose administered on the morning of Day 10 (no evening dose on Day 10).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.1', 'spread': '6.78', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants who were enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-27', 'size': 3838134, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-18T20:52', 'hasProtocol': True}, {'date': '2021-11-16', 'size': 3100830, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-18T20:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-30', 'studyFirstSubmitDate': '2022-04-14', 'resultsFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-30', 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Cmax is maximum plasma concentration .'}, {'measure': 'PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Cmax is maximum plasma concentration'}, {'measure': 'PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration'}, {'measure': 'PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration'}, {'measure': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time Zero to time point on 12 hours'}, {'measure': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.'}, {'measure': 'PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by AUCtau/tau.'}, {'measure': 'PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.'}, {'measure': 'PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.'}, {'measure': 'PF-07321332 Peak-to-trough Ratio (PTR) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by Day 10 Cmax/Day 10 Ctrough.'}, {'measure': 'PF-07321332 Apparent Clearance (CL/F) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral clearance. This was determined by Dose/AUCtau.'}, {'measure': 'PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral volume of distribution.'}, {'measure': 'PF-07321332 Terminal Elimination Half-life (t½) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)', 'description': 'Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.'}, {'measure': 'PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)'}, {'measure': 'PF-07321332 Trough Concentration (Ctrough) on Day 5', 'timeFrame': 'Day 5 (pre-dose)', 'description': 'Concentration at pre-dose on Day 5. Observed directly from data.'}, {'measure': 'PF-07321332 Trough Concentration (Ctrough) on Day 8', 'timeFrame': 'Day 8 (pre-dose)', 'description': 'Concentration at pre-dose on Day 8. Observed directly from data.'}, {'measure': 'PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)', 'timeFrame': 'Day 10 (pre-dose)', 'description': 'Concentration at pre-dose on Day 10. Observed directly from data.'}, {'measure': 'PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)', 'timeFrame': 'Day 10 (12 hours after last dose)', 'description': 'Concentration at 12 hour time on Day 10. Observed directly from data.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From baseline up to Day 42', 'description': 'An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.'}, {'measure': 'Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria', 'timeFrame': 'Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)', 'description': 'Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (\\<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease \\>= 30 mmHg, max. increase \\>=30 mmHg; diastolic BP min. \\<50mmHg; diastolic BP change from baseline max. decrease \\>=20, max. increase \\>=20; seated pulse rate min. \\<40 beats per minute (bpm) and max. \\>120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.', 'description': 'Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria', 'timeFrame': 'Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)', 'description': 'The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds\\[msec\\]) \\>450 and ≤480, or \\>480 and ≤500, or \\>500; Increase from baseline in QTcF (msec) \\>30 and ≤60, or\\>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline \\>200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.'}, {'measure': 'Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Cmax is maximum plasma concentration'}, {'measure': 'Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Cmax is maximum plasma concentration'}, {'measure': 'Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration'}, {'measure': 'Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)', 'description': 'Tmax is the time for maximum plasma concentration'}, {'measure': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1', 'timeFrame': 'Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.'}, {'measure': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.'}, {'measure': 'Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)', 'description': 'Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)'}, {'measure': 'Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'This was determined by AUCtau/tau.'}, {'measure': 'Ritonavir Apparent Clearance (CL/F) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral clearance. This was determined by Dose/AUCtau.'}, {'measure': 'Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)', 'description': 'Apparent oral volume of distribution. This was determined by Dose/(AUCtau\\*kel)'}, {'measure': 'Ritonavir Terminal Elimination Half-life (t½) on Day 10', 'timeFrame': 'Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)', 'description': 'Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.'}, {'measure': 'Ritonavir Trough Concentration (Ctrough) on Day 5', 'timeFrame': 'Day 5 (pre-dose)', 'description': 'Concentration at pre-dose on Day 5. Observed directly from data.'}, {'measure': 'Ritonavir Trough Concentration (Ctrough) on Day 8', 'timeFrame': 'Day 8 (pre-dose)', 'description': 'Concentration at pre-dose on Day 8. Observed directly from data.'}, {'measure': 'Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)', 'timeFrame': 'Day 10 (pre-dose)', 'description': 'Concentration at pre-dose on Day 10. Observed directly from data.'}, {'measure': 'Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)', 'timeFrame': 'Day 10 (12 hours after last dose)', 'description': 'Concentration at 12 hour on Day 10. Observed directly from data.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)', 'coronavirus disease 2019 (COVID-19)'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4671016', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese participants\n* No clinical relevant abnormalities\n* Body mass index (BMI):17.5-28\n\nExclusion Criteria:\n\n* Any clinical significant illness\n* History of alcohol abuse\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose\n* Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)\n* Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate\n* Blood donation within 60 days\n* History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)\n* Other medical or psychiatric may inappropriate for the study'}, 'identificationModule': {'nctId': 'NCT05339334', 'briefTitle': 'A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.', 'orgStudyIdInfo': {'id': 'C4671016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-07321332/ritonavir', 'description': 'PF-07321332/ritonavir will be given by mouth two times a day for 10 days to adult Chinese healthy volunteers', 'interventionNames': ['Drug: PF-07321332/ritonavir']}], 'interventions': [{'name': 'PF-07321332/ritonavir', 'type': 'DRUG', 'description': 'PF-07321332/ritonavir will be given by mouth two times a day for 10 days', 'armGroupLabels': ['PF-07321332/ritonavir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201107', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital,Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}