Healthy Volunteers Clinical Trial
Official title:
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
| Verified date | April 2023 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | November 12, 2022 |
| Est. primary completion date | November 12, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Covance Clinical Research Unit - Dallas | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 2 months | ||
| Primary | Time of maximum observed plasma concentration (Tmax) | Up to 2 months | ||
| Primary | 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 | Number of participants with adverse events (AEs) | Up to 3 months | ||
| Secondary | Number of participants with physical examination findings | Up to 3 months | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 3 months | ||
| Secondary | Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to 3 months | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 3 months |
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