Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-29 @ 3:53 AM
Study NCT ID:
NCT02434861
Status:
COMPLETED
Last Update Posted:
2015-08-25
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578834', 'term': 'rolapitant'}, {'id': 'D004077', 'term': 'Digoxin'}, {'id': 'D012460', 'term': 'Sulfasalazine'}], 'ancestors': [{'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2015-04-30', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC: area under the plasma concentration-time curve', 'timeFrame': 'Predose - up to 120 hours postdose', 'description': 'To evaluate the effect of Rolapitant on the PK of probe substrates'}, {'measure': 'Cmax = observed maximum plasma concentration', 'timeFrame': 'Predose - up to 120 hours postdose', 'description': 'To evaluate the effect of Rolapitant on the PK of probe substrates'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '0 - 38 days', 'description': 'To evaluate the safety and tolerability of combination administration of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and CYP probe substrates (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan \\[Cooperstown Cocktail\\]) with a single dose of rolapitant IV in a healthy adult population, as assessed by incidence and severity of AEs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The objective of this Open Label Study is to evaluate effects of Rolapitant IV solution, and its metabolite, on the pharmacokinetics (PK) of the P-gp substrate (digoxin), the BCRP substrate (sulfasalazine), and multiple cytochrome P450 (CYP) probe substrates in a healthy adult population.', 'detailedDescription': '* Part A will compare the PK of oral digoxin alone and in combination with an IV infusion of rolapitant.\n* Part B will compare the PK of an oral dose of sulfasalazine alone to the PK of an oral dose of sulfasalazine in combination with an IV infusion of rolapitant\n* Part C will compare the PK of an oral dose of the Cooperstown Cocktail (midazolam, omeprazole, warfarin, caffeine, and dextromethorphan) alone and when given in combination with an IV infusion of rolapitant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Main Inclusion Criteria:\n\n* Subjects must be healthy males or females aged 18 to 55 years (inclusive)\n* Female subjects (of childbearing potential) must have a negative pregnancy test at Screening and on Day -1\n* Female subjects of childbearing potential must agree to use an accepted method of birth control (excluding hormonal birth control methods) before Visit 1 and to continue its use during the study and for at least 30 days after the final dose\n* Subjects must have a body mass index (BMI) from 18.5 to 32.0 kg/m2 (inclusive) and a weight of ≥50 kg at Screening\n* Subjects must be capable of understanding the informed consent after the risks and benefits of the study have been explained; subjects must be able to sign a written informed consent and be willing to comply with the protocol requirements\n* Subjects must be in general good health as determined by the Investigator based on pre-study medical and surgical history, physical examination \\[PE\\], and clinical laboratory tests\n\nMain Exclusion Criteria:\n\n* Subjects who have participated in another investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, before the time of the first study dose\n* Subjects who have a history of relevant allergies (including asthma, food, or drug allergies) as determined by the Investigator\n* Subjects who have had significant blood loss, or have donated or received ≥1 units (450 mL) of blood, within 30 days before the first study dose\n* Subjects who have a history of hypersensitivity to rolapitant IV or any of its excipients or who have participated in a previous rolapitant study within 6 months prior to administration of the first dose of study drug (Day 1)\n* Subjects with poor venous access and/or cannot tolerate venipuncture\n* Subjects with a history of significant complications or anxiety associated with the IV administration of medications that, in the opinion of the Investigator, could make the subject\n* Subjects who have a history of hypersensitivity to sulfasalazine (Part B only)."}, 'identificationModule': {'nctId': 'NCT02434861', 'briefTitle': 'An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (2 mg/mL IV Solution) on the Pharmacokinetics of Digoxin; Sulfasalazine; and the Cooperstown Cocktail (Midazolam, Omeprazole, Warfarin, Caffeine, and Dextromethorphan in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tesaro, Inc.'}, 'officialTitle': 'An Open Label, Single Dose, Three Part Study to Assess the Effects of Rolapitant (1.8 mg/mL Rolapitant IV Solution) on the Pharmacokinetics of Digoxin (P-gp); Sulfasalazine (BCRP); and the Cooperstown Cocktail (Midazolam [CYP3A4], Omeprazole [CYP2C19], Warfarin [CYP2C9], Caffeine [CYP1A2], and Dextromethorphan [CYP2D6]) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'PR-11-5021-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Rolapitant IV and Digoxin', 'interventionNames': ['Drug: Rolapitant', 'Drug: Digoxin']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Rolapitant IV and Sulfasalazine', 'interventionNames': ['Drug: Rolapitant', 'Drug: Sulfasalazine']}, {'type': 'EXPERIMENTAL', 'label': 'Part C', 'description': 'Rolapitant IV and Cooperstown Cocktail', 'interventionNames': ['Drug: Rolapitant', 'Drug: Cooperstown Cocktail']}], 'interventions': [{'name': 'Rolapitant', 'type': 'DRUG', 'armGroupLabels': ['Part A', 'Part B', 'Part C']}, {'name': 'Digoxin', 'type': 'DRUG', 'description': 'P-gp substrate', 'armGroupLabels': ['Part A']}, {'name': 'Sulfasalazine', 'type': 'DRUG', 'description': 'BCRP substrate', 'armGroupLabels': ['Part B']}, {'name': 'Cooperstown Cocktail', 'type': 'DRUG', 'description': 'Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan', 'armGroupLabels': ['Part C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel Early Phase Unit', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Dennis Vargo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tesaro, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tesaro, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}