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An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants

NCT ID: NCT03660436

Last Updated: 2018-12-19

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

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-14

Study Completion Date

2018-10-18

Brief Summary

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The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.

Detailed Description

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Conditions

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Healthy Participants

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-986165 + MMF

Oral administration

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

MMF

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986165

Specified dose on specified days

Intervention Type DRUG

MMF

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Mycophenolate Mofetil

Eligibility Criteria

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Inclusion Criteria

* Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) \> 80 mL/min/1.732 m2

Exclusion Criteria

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Positive anti- John Cunningham virus (JCV) antibody test at Screening
* History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
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: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PRA Health Sciences

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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IM011-071

Identifier Type: -

Identifier Source: org_study_id