A Study Investigating Interactions Between BMS-986322 and Rosuvastatin, Metformin and Methotrexate in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: BMS-986322
* Drug: Rosuvastatin
* Drug: Metformin
* Dietary Supplement: Glucose
* Drug: Methotrexate
* Drug: Leucovorin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: Rosuvastatin + BMS-986322<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Drug: Rosuvastatin<br>* Specified dose on specified days<br>|
| Experimental: Part 2: Metformin + BMS-986322 + Glucose<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Drug: Metformin<br>* Specified dose on specified days<br>Dietary Supplement: Glucose<br>* Specified dose on specified days<br>|
| Experimental: Part 3: Methotrexate + BMS-986322 + Leucovorin<br> | Drug: BMS-986322<br>* Specified dose on specified days<br>Drug: Methotrexate<br>* Specified dose on specified days<br>Drug: Leucovorin<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 21 days | 
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of maximum observed plasma concentration (Tmax) |  | Up to 21 days | 
| Apparent terminal phase half-life (T-HALF) |  | Up to 21 days | 
| 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 physical examination abnormalities |  | Up to 51 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 51 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMS-986322, Rosuvastatin, Metformin, Methotrexate