A Study to Assess 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
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05389722
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 2 CC-92480 - Part 2 Itraconazole - Part 3 CC-92480 - Part 3 Digoxin - Part 1 CC-92480 - Part 1 Rifampin - Part 3 Rosuvastatin -
- Primary Outcome Measures
Name Time Method Time of maximum observed plasma concentration (Tmax) Up to 2 months Maximum observed plasma concentration (Cmax) 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
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 3 months Number of participants with physical examination findings Up to 3 months Number of participants with vital sign abnormalities Up to 3 months Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to 3 months Number of participants with clinical laboratory abnormalities Up to 3 months
Trial Locations
- Locations (1)
Covance Clinical Research Unit - Dallas
🇺🇸Dallas, Texas, United States
Covance Clinical Research Unit - Dallas🇺🇸Dallas, Texas, United States