Evaluate the Bioavailability Between 2 BMS-986141 Formulations in Healthy Participants

March 21, 2018 updated by: Bristol-Myers Squibb

A Randomized Study to Evaluate the Bioavailability of BMS-986141 From a Form B Tablet Formulation Relative to the Form A Reference Tablet in Healthy Participants

Open label, randomized, 4-period crossover study with single doses of BMS-986141 given to healthy female subjects of non-childbearing potential and healthy males.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
  • Body mass index 18.0 kg/m2 to 32.0 kg/m2
  • females must be of non-childbearing potential

Exclusion Criteria:

  • known bleeding or coagulation disorders
  • acute or chronic medical illness
  • history of nausea or chronic diarrhea that lasts over 4 weeks
  • history of periodontal disease or gingivitis which required treatment
  • other exclusion criteria may apply

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: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Single oral dose BMS-986141 Form A tablet under fasting conditions
Drug: BMS-986141 Form A Tablet
tablet
EXPERIMENTAL: B
Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions
Drug: BMS-986141 Form B tablet (low dose)
tablet
EXPERIMENTAL: C
Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions
Drug: BMS-986141 Form B tablet (high dose)
tablet
EXPERIMENTAL: D
Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions
Drug: BMS-986141 Form B tablet (high dose)
tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the bioavailability between BMS-986141 Form B tablet compared to the Form A reference tablet
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Further characterize safety and tolerability of BMS-986141 by assessing adverse events and other physical assessments throughout study conduct
Time Frame: 4 weeks
4 weeks

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 (ACTUAL)

January 25, 2017

Primary Completion (ACTUAL)

February 7, 2017

Study Completion (ACTUAL)

February 7, 2017

Study Registration Dates

First Submitted

December 23, 2016

First Submitted That Met QC Criteria

January 26, 2017

First Posted (ESTIMATE)

January 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • CV006-023
  • 2016-001031-13 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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