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Pharmacokinetics and Metabolism Study in Healthy Male Participants

NCT ID: NCT03247283

Last Updated: 2017-11-06

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2017-10-15

Brief Summary

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Phase 1 Phamacokinetic and metabolism study of BMS-986205 in healthy males

Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Single Oral Dose of BMS-986205

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

Carbon 14 tagged BMS-986205

Interventions

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BMS-986205

Carbon 14 tagged BMS-986205

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body weight 75-95kg, BMI 18.0-32.0 kg/m\^2
* Refrain from sperm donation 110 days after dosing

Exclusion Criteria

* Current or recent gastrointestinal disease
* Any GI surgery that could impact drug absorption
* Active, known, or suspected autoimmune disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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: PRINCIPAL_INVESTIGATOR

Bristol-Myers Squibb

Locations

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Covance Clinical Research Unit, Inc.

Madison, Wisconsin, 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 Education Resource

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

Investigator Inquiry Form

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

Other Identifiers

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CA017-052A

Identifier Type: -

Identifier Source: org_study_id