A Study of BMS-986195 in Healthy Male Subjects

NCT ID: NCT03245515

Last Updated: 2018-01-05

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2017-10-05

Brief Summary

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The purpose of this study is to investigate the effects BMS-986195 in healthy male subjects.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986195

A single oral solution dose of BMS-986195

Group Type EXPERIMENTAL

BMS-986195

Intervention Type DRUG

specified dose on specified days

Interventions

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BMS-986195

specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male subjects, if not surgically sterilized, must agree to use adequate contraception
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive (BMI = weight \[kg\]/\[height (m)\]2), and total body weight \>50 kg
* All prescribed medication, including live vaccinations, must have been stopped at least 30 days prior to admission to the clinical research center
* All over-the-counter (OTC ) medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's Wort) must have been stopped at least 14 days prior to admission to the clinical research center
* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks), and grapefruit (juice) from 3 days prior to admission to the clinical research center
* Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG and vital signs, as judged by the Principal Investigator

Exclusion Criteria

* Previous participation in the current study
* Known previous exposure to BMS-986195
* Employee of PRA or the Sponsor
* History of relevant drug and/or food allergies, including allergy to immunologic or related compounds or allergy to seafood or marine products
* Using tobacco products within 60 days prior to drug administration
* Positive screen for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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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Local Institution

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Related Links

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Other Identifiers

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2017-002706-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM014-016

Identifier Type: -

Identifier Source: org_study_id

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