Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-25 @ 7:20 PM
Study NCT ID:
NCT05960032
Status:
COMPLETED
Last Update Posted:
2025-01-06
First Post:
2023-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquires@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': 'Day 1 up to maximum of 35 days post single dose administration', 'eventGroups': [{'id': 'EG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Laryngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nasal mucosal discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nasal mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Urticaria papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.32', 'spread': '114', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Maximum plasma concentration (Cmax) was measured.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.25', 'spread': '122', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.'}, {'type': 'PRIMARY', 'title': 'AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.53', 'spread': '128', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'title': 'With all-causality TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'With treatment-related TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration', 'description': 'An 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, including untoward findings on physical examinations captured as AEs if any.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took study intervention were included in the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took study intervention were included in the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Values of Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took study intervention were included in the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Values of 12-lead ECGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who took study intervention were included in the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.584', 'groupId': 'OG000', 'lowerLimit': '0.333', 'upperLimit': '1.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Tmax, time to Cmax, was measured.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.'}, {'type': 'SECONDARY', 'title': 't1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.00', 'spread': '1.4929', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'T1/2, terminal half-life, was measured.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.'}, {'type': 'SECONDARY', 'title': 'CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '186.8', 'spread': '128', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'CL/F, apparent clearance, was measured.', 'unitOfMeasure': 'Liter/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.'}, {'type': 'SECONDARY', 'title': 'Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2943', 'spread': '141', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Vz/F, apparent volume of distribution, was measured.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population refers to all participants who were dosed and had at least 1 of the PK parameters of secondary interest.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'periods': [{'title': 'TREATMENT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'FOLLOW-UP', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 13 participants were enrolled and 12 participants received 1 dose of study intervention, and all 12 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Zavegepant IN 10 mg', 'description': 'Zavegepant 10 mg was administered intranasally (IN) on Day 1.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<18 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '18-25 Years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '26-35 Years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '36-45 Years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '>45 Years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received study treatments were included in baseline analysis population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-20', 'size': 509536, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-14T15:03', 'hasProtocol': True}, {'date': '2023-04-17', 'size': 207547, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-11-14T15:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-07-16', 'resultsFirstSubmitDate': '2024-11-14', 'studyFirstSubmitQcDate': '2023-07-16', 'lastUpdatePostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-14', 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Maximum plasma concentration (Cmax) was measured.'}, {'measure': 'AUClast of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'AUClast, area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast), was measured.'}, {'measure': 'AUCinf of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'AUCinf, area under the plasma concentration-time curve from time 0 extrapolated to infinite time, was measured.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration', 'description': 'An 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, including untoward findings on physical examinations captured as AEs if any.'}, {'measure': 'Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration'}, {'measure': 'Number of Participants With Clinically Significant Values of Vital Signs', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration'}, {'measure': 'Number of Participants With Clinically Significant Values of 12-lead ECGs', 'timeFrame': 'Day 1 up to maximum of 35 days post single dose administration'}, {'measure': 'Tmax of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Tmax, time to Cmax, was measured.'}, {'measure': 't1/2 of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'T1/2, terminal half-life, was measured.'}, {'measure': 'CL/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'CL/F, apparent clearance, was measured.'}, {'measure': 'Vz/F of Zavegepant in Plasma Following Single Dose of Zavegepant 10 mg IN', 'timeFrame': '0 (pre-dose), 5 min, 10 min, 20 min, 30 min, 40 min, 50 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours post dose on Day 1', 'description': 'Vz/F, apparent volume of distribution, was measured.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zavegepant', 'Healthy volunteer'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5301009', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about:\n\n* how Zavegepant is changed and removed from the body after taken.\n* safety of Zavegepant.\n* the extent to which side effects can be tolerated after taking Zavegepant for the possible short-term treatment of migraine.\n\nThis study is seeking participants who:\n\n* are healthy Chinese adults and includes participants who are between 18 to 55 years old.\n* have body mass index (BMI) of 18 to 30 kg/m\\^2.\n* have a total body weight of:\n* equal to or more than 50 kilograms (110 pounds) for males.\n* equal to or more than 45 kilograms (99 pounds) for females.\n* are non-smoker (no use of tobacco or nicotine products).\n\nAll participants in this study will receive Zavegepant by nose, once at the study clinic.\n\nThe experiences of the participants receiving the study medicine will be looked at. This will help see if the study medicine is safe.\n\nParticipants will take part in this study for around 9 weeks. During this time, participants will have 2 study visits at the study clinic and 1 contact over the phone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese adults and includes participants who are between 18 to 55 years old\n* BMI of 18 to 30 kg/m\\^2; and a total body weight ≥50 kg (110 lb) for males and ≥45 kg (99 lb) for females\n* Non-smoker (no use of tobacco or nicotine products).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease.\n* Use of medication other than topical products without significant systemic absorption.\n* Previous participantion in a clinical research study or investigational study prior to the first dosing.\n* Any clinically significant abnormal laboratory test results or positive test.\n* Evidence of organ dysfunction or any clinically significant deviation from normal.\n* Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic).\n* Standard 12-lead ECG that demonstrates clinically relevant abnormalities.\n* Abnormalities in clinical laboratory tests: AST or ALT level \\> ULN; Total bilirubin level \\> ULN; ANC or ALC level \\> ULN.\n* Positive urine drug screen, alcohol breath test, or urine cotinine test.\n* Positive pregnancy test.\n* Positive result for COVID-19.\n* History of significant alcohol abuse or drug abuse.\n* History of anaphylaxix reaction or a clinically important reaction to any drug.\n* Donation of plasma within 30 days prior to dosing. Donation or loss of blood of approximately 400 mL or more within 60 days prior to dosing.\n* Inability to be venipunctured and/or tolerate catheter venous access.\n* Habitual use of snuff tobacco.\n* History of sensitivity to heparin or heparin-induced thrombocytopenia.'}, 'identificationModule': {'nctId': 'NCT05960032', 'briefTitle': 'A Study to Learn About the Study Medicine Called Zavegepant in Healthy Chinese Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF ZAVEGEPANT INTRANASAL ADMINISTRATION IN HEALTHY CHINESE ADULT PARTICIPANTS', 'orgStudyIdInfo': {'id': 'C5301009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zavegepant', 'description': 'Participants receiving Zavegepant for the treatment phase of the study', 'interventionNames': ['Drug: Zavegepant']}], 'interventions': [{'name': 'Zavegepant', 'type': 'DRUG', 'description': 'Participants receiving single dose of Zavegepant 10 mg', 'armGroupLabels': ['Zavegepant']}]}, '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'}}}}