A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Participants
- Interventions
- Dietary Supplement: Glucose
- Registration Number
- NCT05615012
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Rosuvastatin + BMS-986322 BMS-986322 - Part 2: Metformin + BMS-986322 + Glucose BMS-986322 - Part 2: Metformin + BMS-986322 + Glucose Glucose - Part 3: Methotrexate + BMS-986322 + Leucovorin Methotrexate - Part 3: Methotrexate + BMS-986322 + Leucovorin BMS-986322 - Part 1: Rosuvastatin + BMS-986322 Rosuvastatin - Part 2: Metformin + BMS-986322 + Glucose Metformin - Part 3: Methotrexate + BMS-986322 + Leucovorin Leucovorin -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 21 days Maximum observed plasma concentration (Cmax) Up to 21 days Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) Up to 21 days
- Secondary Outcome Measures
Name Time Method Apparent total body clearance (CLT/F) Up to 21 days Number of participants with adverse events (AEs) Up to 51 days Number of participants with vital sign abnormalities Up to 51 days Number of participants with electrocardiogram (ECG) abnormalities Up to 51 days Number of participants with clinical laboratory abnormalities Up to 51 days Number of participants with physical examination abnormalities Up to 51 days Time of maximum observed plasma concentration (Tmax) Up to 21 days Apparent terminal phase half-life (T-HALF) Up to 21 days
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Miami, Florida, United States