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Safety and Tolerability Study of BMS-986177 in Healthy Subjects

NCT ID: NCT02608970

Last Updated: 2017-07-31

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

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-07-23

Brief Summary

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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects

Detailed Description

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Conditions

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Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BMS-986177

BMS-986177 specified dose on specified days

Group Type EXPERIMENTAL

BMS-986177

Intervention Type DRUG

Placebo

Placebo specified dose on specified days

Group Type OTHER

Placebo

Intervention Type OTHER

Interventions

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BMS-986177

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive

Exclusion Criteria

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
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

Bristol-Myers Squibb

Locations

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SGS Belgium NV

Antwerp, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

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

BMS clinical trial educational resource

Other Identifiers

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2015-003065-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CV010-001

Identifier Type: -

Identifier Source: org_study_id