A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2019-09-12

Brief Summary

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A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.

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Detailed Description

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A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants

Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Monotherapy SAD BMS-986318 or Placebo

Single Ascending Dose (SAD)

Group Type EXPERIMENTAL

BMS-986318

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Placebo Matching BMS-986318

Monotherapy MAD BMS-986318 or Placebo

Multiple Ascending Dose (MAD)

Group Type EXPERIMENTAL

BMS-986318

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Placebo Matching BMS-986318

Interventions

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BMS-986318

Specified dose on specified days

Intervention Type DRUG

Placebo

Placebo Matching BMS-986318

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
* Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
* Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.

Exclusion Criteria

* Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
* Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
* Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes