Healthy Participants Clinical Trial
Official title:
An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State BMS-986322 on the Pharmacokinetics of Rosuvastatin (Part 1), the Pharmacokinetics and Pharmacodynamics of Metformin (Part 2) and the Pharmacokinetics of Methotrexate (Part 3) in Healthy Participants
| Verified date | March 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to assess the effect of coadministration of multiple oral doses of BMS-986322 with rosuvastatin, metformin, and methotrexate in healthy participants.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | December 13, 2023 |
| Est. primary completion date | December 13, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | Inclusion Criteria: - In the opinion of the investigator, a healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations. - Body mass index (BMI) of 18.0 kilogram (kg)/meter(m)^2 to 30.0 kg/m^2, inclusive, and body weight = 50 kg for males and = 45 kg for females, at screening. - A female participant is eligible to participate if she is a woman not of childbearing potential. - Female participants must refrain from donating oocytes during the intervention period and for at least 5 half-lives (5 days) after the last dose of study intervention. - For Parts 1 and 2 participants must be 18 to 60 years of age. - For Part 3 participants must be 18 to 50 years of age. Exclusion Criteria: - Any significant acute or chronic medical illness. - Any major surgery, including any gastrointestinal (GI) surgery, with the exception of appendectomy, within 90 days of study intervention administration. - History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women or 14 units for men of alcohol per week (1 unit = 340 mililitre [mL] of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%). - Participant must not have a known or suspected immune-mediated disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status. - Participant must not have any history or risk for tuberculosis (TB) in participants with current clinical, radiographic, or laboratory evidence of active TB. Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0001 | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 21 days | ||
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | Up to 21 days | ||
| Primary | Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Up to 21 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 21 days | ||
| Secondary | Apparent terminal phase half-life (T-HALF) | Up to 21 days | ||
| Secondary | Apparent total body clearance (CLT/F) | Up to 21 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 51 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 51 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 51 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 51 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 51 days |
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