Effect of BMS-986165 on the Blood Levels of Metformin

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986165; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04671953

IM011-159

Details and patient eligibility

About

The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
• Body mass index of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
• Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

• Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Arm 1: BMS-986165 Dose 1 + Metformin

Experimental group

Treatment:

Drug: Metformin

Drug: BMS-986165

Arm 2: BMS-986165 Dose 2 + Metformin

Experimental group

Treatment:

Drug: Metformin

Drug: BMS-986165