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

NCT ID: NCT03362437

Last Updated: 2018-03-14

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2017-12-28

Brief Summary

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

Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

Receive 200 mg BMS-986177 Form A without food

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Form A

Treatment B

Receive 200 mg BMS-986177 Form B without food

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Form B

Treatment C

Receive 200 mg BMS-986177 Form B with food

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Form B

Interventions

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BMS-986177

Form A

Intervention Type DRUG

BMS-986177

Form B

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Briston-Myers Squibb

Locations

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Quotient Clinical

Ruddington, Nottingham, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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CV010-020

Identifier Type: -

Identifier Source: org_study_id

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