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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986322; Drug: Rosuvastatin; Drug: Leucovorin; Drug: Metformin; Dietary Supplement: Glucose; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05615012

IM032-039

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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76 participants in 3 patient groups

Part 1: Rosuvastatin + BMS-986322

Experimental group

Treatment:

Drug: Rosuvastatin

Drug: BMS-986322

Part 2: Metformin + BMS-986322 + Glucose

Experimental group

Treatment:

Dietary Supplement: Glucose

Drug: Metformin

Drug: BMS-986322

Part 3: Methotrexate + BMS-986322 + Leucovorin

Experimental group

Treatment:

Drug: Methotrexate

Drug: Leucovorin

Drug: BMS-986322