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
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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
June 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2022
CompletedApril 19, 2023
April 1, 2023
5 months
May 20, 2022
April 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
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
Study Arms (3)
Part 1
EXPERIMENTALPart 2
EXPERIMENTALPart 3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance Clinical Research Unit - Dallas
Dallas, Texas, 75247-4968, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2022
First Posted
May 25, 2022
Study Start
June 9, 2022
Primary Completion
November 12, 2022
Study Completion
November 12, 2022
Last Updated
April 19, 2023
Record last verified: 2023-04