A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-27

Study Completion Date

2020-02-11

Brief Summary

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The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A: BMS-986165 alone, fasted

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Single dose

Treatment B: BMS-986165 alone, fed

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Single dose

Treatment C: BMS-986165 with famotidine pretreatment, fasted

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Single dose

Famotidine

Intervention Type DRUG

Single dose

Interventions

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BMS-986165

Single dose

Intervention Type DRUG

Famotidine

Single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
* Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
* All female subjects must have a negative serum or urine pregnancy test

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.
* History of administration of live vaccines within 60 days before screening until clinic discharge
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes