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A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

NCT ID: NCT02293629

Last Updated: 2015-05-19

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2014-11-30

Brief Summary

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This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.

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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

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1: BMS-986147 or Placebo matching BMS-986147

Single oral dose as specified

Group Type PLACEBO_COMPARATOR

BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

A2: BMS-986147 or Placebo matching BMS-986147

Single oral dose as specified

Group Type PLACEBO_COMPARATOR

BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

A3: BMS-986147 or Placebo matching BMS-986147

Single oral dose as specified

Group Type PLACEBO_COMPARATOR

BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

B1: BMS-986147 or Placebo matching BMS-986147

Daily oral dose as specified

Group Type ACTIVE_COMPARATOR

BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

B2: BMS-986147 or Placebo matching BMS-986147

Daily oral dose as specified

Group Type ACTIVE_COMPARATOR

BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

Interventions

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BMS-986147

Intervention Type DRUG

Placebo matching BMS-986147

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women, ages 18 to 45 years
* Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
* Women of child bearing potential are eligible for enrollment.
* Women must have a negative pregnancy test

Exclusion Criteria

* Evidence of organ dysfunction
* Any significant acute or chronic medical illness
* Inability to: tolerate oral medications, be venipunctured
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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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Wcct Global, Llc

Cypress, California, United States

Site Status

Countries

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United States

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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IM008-003

Identifier Type: -

Identifier Source: org_study_id

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