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
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1
|
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Rifampin
Specified dose on specified days
|
Experimental: Part 2
|
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Itraconazole
Specified dose on specified days
|
Experimental: Part 3
|
Drug: CC-92480
Specified dose on specified days
Other Names:
Drug: Digoxin
Specified dose on specified days
Drug: Rosuvastatin
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- CA057-002