An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Male Volunteers

Treatments: Drug: BMS-986165; Drug: Pyrimethamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04086719

IM011-100

Details and patient eligibility

About

Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine

Enrollment: 16 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients must be willing and able to complete all study-specific procedures and visits
• Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
• Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
• Normal renal function at screening

Exclusion criteria

• Any 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
• Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
• History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

BMS- 986185 + Pyrimethamine

Experimental group

Treatment:

Drug: Pyrimethamine

BMS-986185

Experimental group

Treatment:

Drug: BMS-986165