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

NCT ID: NCT03035734

Last Updated: 2018-03-23

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2017-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Single oral dose BMS-986141 Form A tablet under fasting conditions

Group Type ACTIVE_COMPARATOR

BMS-986141 Form A Tablet

Intervention Type DRUG

tablet

B

Single oral dose BMS-986141 Form B tablet (low-dose) under fasting conditions

Group Type EXPERIMENTAL

BMS-986141 Form B tablet (low dose)

Intervention Type DRUG

tablet

C

Single oral dose BMS-986141 Form B tablet (high-dose) under fasting conditions

Group Type EXPERIMENTAL

BMS-986141 Form B tablet (high dose)

Intervention Type DRUG

tablet

D

Single oral dose BMS-986141 Form B tablet (high-dose) under fed conditions

Group Type EXPERIMENTAL

BMS-986141 Form B tablet (high dose)

Intervention Type DRUG

tablet

Interventions

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BMS-986141 Form A Tablet

tablet

Intervention Type DRUG

BMS-986141 Form B tablet (low dose)

tablet

Intervention Type DRUG

BMS-986141 Form B tablet (high dose)

tablet

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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

Bristol-Myers Squibb

Related Links

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http://www.bms.com/studyconnect/pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator inquiry form

Other Identifiers

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2016-001031-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV006-023

Identifier Type: -

Identifier Source: org_study_id

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