A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Montelukast; Drug: Midazolam; Drug: Omeprazole; Drug: Caffeine; Drug: BMS-986196; Drug: Pravastatin; Drug: Flurbiprofen; Drug: Digoxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05852769

IM038-022

Details and patient eligibility

About

This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
• Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.

Exclusion criteria

• History of rhabdomyolysis.
• History of peptic ulcer disease or significant GI bleeding.
• History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

BMS-986196 and/or Cocktail Probe Substrate Drugs

Experimental group

Treatment:

Drug: Montelukast

Drug: BMS-986196

Drug: Pravastatin

Drug: Flurbiprofen

Drug: Omeprazole

Drug: Caffeine

Drug: Digoxin

Drug: Midazolam