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

May 18, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • WCCT Global, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: A1: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
Drug: BMS-986147
Drug: Placebo matching BMS-986147
Placebo Comparator: A2: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
Drug: BMS-986147
Drug: Placebo matching BMS-986147
Placebo Comparator: A3: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
Drug: BMS-986147
Drug: Placebo matching BMS-986147
Active Comparator: B1: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
Drug: BMS-986147
Drug: Placebo matching BMS-986147
Active Comparator: B2: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
Drug: BMS-986147
Drug: Placebo matching BMS-986147

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Up to 30 days post last dose of study drug
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
Up to 30 days post last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 14, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 18, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IM008-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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