Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT01244620
Status:
TERMINATED
Last Update Posted:
2012-02-22
First Post:
2010-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106276', 'term': 'sitaxsentan'}, {'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'D000068677', 'term': 'Sildenafil Citrate'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011687', 'term': 'Purines'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Study endpoints were not analyzed due to early termination.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days', 'otherNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'PRIMARY', 'title': 'Trough Plasma Concentrations (Ctrough)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Minimum or "trough"concentrations', 'unitOfMeasure': 'nanograms (ng)/milliliter (mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'unitOfMeasure': 'micrograms per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve of the 24 Hour Dosing Interval (AUC24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'unitOfMeasure': 'nanogram hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'mL/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution at Steady State (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sitaxsentan', 'description': 'Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG001', 'title': 'Tadalafil', 'description': 'Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG002', 'title': 'Sitaxsentan and Tadalafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'OG003', 'title': 'Sitaxsentan and Sildenafil', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not analyzed due to early study termination.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild', 'description': 'Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'FG001', 'title': 'Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad', 'description': 'Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'FG002', 'title': 'Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.'}, {'id': 'FG003', 'title': 'Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax', 'description': 'Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study was terminated for safety reasons (hepatoxicity) after dosing was completed for the first intervention.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'All randomized participants'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.9', 'spread': '7.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Safety Issue: The trial was prematurely terminated on Dec 9, 2010, due to safety concerns, specifically new emerging evidence of hepatic injury.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2010-11-15', 'resultsFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-18', 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)'}, {'measure': 'Trough Plasma Concentrations (Ctrough)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Minimum or "trough"concentrations'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)'}, {'measure': 'Area Under the Curve of the 24 Hour Dosing Interval (AUC24)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)'}, {'measure': 'Apparent Oral Clearance (CL/F)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Volume of Distribution at Steady State (Vss)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.'}], 'secondaryOutcomes': [{'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': 'Day 6 (predose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post dose)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['A pharmacokinetic drug-drug interaction study between sitaxsentan and tadalafil and between sitaxsentan and sildenafil at the steady-state'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1321056&StudyName=A%20Pharmacokinetic%20Drug-Drug%20Interaction%20%28DDI%29%20Study%20Between%20Sitaxsentan%20And%20Sildenafil%2C%20And%20Between%20Sitaxsentan%20And%20Tadalafil%20After%20Mult', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Sitaxsentan has a low drug-drug interaction potential and it did not have a clinically relevant effect on pharmacokinetics of sildenafil (a CYP3A sensitive substrate and PDE5 inhibitor).\n\nTadalafil did not have clinically relevant effect on pharmacokinetics of bosentan and ambrisentan. Based on overall clinical drug-drug interaction profiles, and in vitro CYP enzymes and transporter data, a clinically relevant drug-drug interaction between sitaxsentan and tadalafil is not expected. Sildenafil is not expected to affect sitaxsentan pharmacokinetics (PK), as sitaxsentan is a substrate of CYP3A4 and CYP2C9, where sildenafil did not show clinically relevant effect on PK of substrates of CYP3A4 and CYP2C9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects and women of non-child bearing potential between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>45 kg (99 lbs).\n* An informed consent document signed and dated by the subject or a legally acceptable representative.\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or clinical findings at Screening.\n* A positive urine drug screen.\n* Subjects with hepatic dysfunction, defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\>1.5 times the upper limit of the normal range at Screening. A retest may be done if AST and/or ALT within 1.5- to 2- times the upper limit of the normal range at Screening, and the average of the first and repeated test values should be used to decide the eligibility.'}, 'identificationModule': {'nctId': 'NCT01244620', 'briefTitle': 'A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B1321056'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'sitaxsentan 100 mg QD for 6 days (Treatment A)', 'interventionNames': ['Drug: sitaxentan']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'tadalafil 40 mg QD for 6 days', 'interventionNames': ['Drug: tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'sitaxsentan 100 mg QD co-administered with tadalafil 40 mg QD for 6 days', 'interventionNames': ['Drug: sitaxsentan', 'Drug: tadalafil']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'sitaxsentan 100 mg QD co-administered with sildenafil 20 mg TID for 6 days', 'interventionNames': ['Drug: sitaxsentan', 'Drug: sildenafil']}], 'interventions': [{'name': 'sitaxentan', 'type': 'DRUG', 'otherNames': ['Thelin'], 'description': 'sitaxsentan 100 mg QD for 6 days', 'armGroupLabels': ['Treatment A']}, {'name': 'tadalafil', 'type': 'DRUG', 'description': 'tadalafil 40 mg QD for 6 days', 'armGroupLabels': ['Treatment B']}, {'name': 'sitaxsentan', 'type': 'DRUG', 'description': 'sitaxsentan 100 mg QD for 6 days', 'armGroupLabels': ['Treatment C']}, {'name': 'tadalafil', 'type': 'DRUG', 'description': 'tadalafil 40 mg QD for 6 days', 'armGroupLabels': ['Treatment C']}, {'name': 'sitaxsentan', 'type': 'DRUG', 'description': 'sitaxentan 100 mg QD for 6 days', 'armGroupLabels': ['Treatment D']}, {'name': 'sildenafil', 'type': 'DRUG', 'description': 'sildenafil 20 mg TID for 6 days', 'armGroupLabels': ['Treatment D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}