Clinical trial

A Phase 1, Parallel-group, 3-part, 2-period, Fixed-sequence, Crossover, Open-label, Nonrandomized, Drug-drug Interaction Study to Assess the Pharmacokinetics of CC-92480 (BMS-986348) After Coadministration With Rifampin and Itraconazole, and Pharmacokinetics of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

Name
CA057-002
Description
The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.
Trial arms
Trial start
2022-06-09
Estimated PCD
2022-11-12
Trial end
2022-11-12
Status
Completed
Phase
Early phase I
Treatment
CC-92480
Specified dose on specified days
Arms:
Part 1, Part 2, Part 3
Other names:
BMS-986348
Rifampin
Specified dose on specified days
Arms:
Part 1
Itraconazole
Specified dose on specified days
Arms:
Part 2
Digoxin
Specified dose on specified days
Arms:
Part 3
Rosuvastatin
Specified dose on specified days
Arms:
Part 3
Size
24
Primary endpoint
Maximum observed plasma concentration (Cmax)
Up to 2 months
Time of maximum observed plasma concentration (Tmax)
Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 2 months
Eligibility criteria
Inclusion Criteria: * Must have a body mass index between 18 and 33 kg/m2 (inclusive) * Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments Exclusion Criteria: * Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion * Any major surgery within 4 weeks of the first dose administration * History of drug abuse within 2 years of the first dose administration Other protocol-defined inclusion/exclusion criteria apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2023-04-19

1 organization

5 products

1 indication

Product
CC-92480
Product
Rifampin
Product
Digoxin