Skip to main content
OpenTrials
Completed

NCT Number: NCT02293629

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wcct Global, Llc

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Healthy men and women, ages 18 to 45 years
  • Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
  • Women of child bearing potential are eligible for enrollment.
  • Women must have a negative pregnancy test

Exclusion criteria

  • Evidence of organ dysfunction
  • Any significant acute or chronic medical illness
  • Inability to: tolerate oral medications, be venipunctured

Treatment and study plan

BMS-986147

Drug

Placebo matching BMS-986147

Drug

Primary outcomes

  1. Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations

    Time frame: Up to 30 days post last dose of study drug

    Adverse event (AE)

  2. Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations

    Time frame: Up to 30 days post last dose of study drug

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2014
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.