Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants

March 13, 2018 updated by: Bristol-Myers Squibb

A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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 Kingdom
    • Nottingham
      • Ruddington, Nottingham, United Kingdom, NG11 6JS
        • Quotient Clinical

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 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index 18.0 to 32.0 kg/m2, inclusive
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria:

  • Any significant acute or chronic medical illness
  • Head injury in the last 2 years
  • History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could 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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
Receive 200 mg BMS-986177 Form A without food
Drug: BMS-986177
Form A
Drug: BMS-986177
Form B
Experimental: Treatment B
Receive 200 mg BMS-986177 Form B without food
Drug: BMS-986177
Form A
Drug: BMS-986177
Form B
Experimental: Treatment C
Receive 200 mg BMS-986177 Form B with food
Drug: BMS-986177
Form A
Drug: BMS-986177
Form B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 3 days
Measured by plasma concentration
Up to 3 days
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Time Frame: Up to 3 days
Measured by plasma concentration
Up to 3 days
AUC from time zero extrapolated to infinite time (AUC(INF))
Time Frame: Up to 3 days
Measured by plasma concentration
Up to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events (AEs)
Time Frame: Up to 12 days
Safety and tolerability as measured by incidence of AEs
Up to 12 days
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 30 days
Safety and tolerability as measured by incidence of SAEs
Up to 30 days
Number of participants with electrocardiogram abnormalities
Time Frame: Up to 12 days
Up to 12 days
Number of participants with physical examination abnormalities
Time Frame: Up to 12 days
Up to 12 days
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 12 days
Up to 12 days

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Briston-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)

November 15, 2017

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

December 28, 2017

Study Registration Dates

First Submitted

November 30, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 14, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV010-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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