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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-12

Study Completion Date

2019-10-29

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS- 986185 + Pyrimethamine

Group Type EXPERIMENTAL

Pyrimethamine

Intervention Type DRUG

Oral administration of Pyrimethamine in combination with BMS-986185

BMS-986185

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Oral administration of tablet BMS- 986165

Interventions

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BMS-986165

Oral administration of tablet BMS- 986165

Intervention Type DRUG

Pyrimethamine

Oral administration of Pyrimethamine in combination with BMS-986185

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes