Pharmacokinetics (Drug Levels in Blood) of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants

NCT ID: NCT04249284

Last Updated: 2020-04-09

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-06

Study Completion Date

2020-03-15

Brief Summary

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The purpose of this study is to characterize the pharmacokinetics (the way the body absorbs, distributes and eliminates the drug) of BMS 986165 given in the form of various prototypes of solid tablets to healthy participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A : BMS-986165

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

Treatment B: BMS-986165 prototype 1

Group Type EXPERIMENTAL

BMS-986165 prototype 1

Intervention Type DRUG

Specified dose on specified days

Treatment C: BMS-986165 prototype 2

Group Type EXPERIMENTAL

BMS-986165 prototype 2

Intervention Type DRUG

Specified dose on specified days

Treatment D: BMS-986165 prototype 2

Group Type EXPERIMENTAL

BMS-986165 prototype 2

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986165

Specified dose on specified days

Intervention Type DRUG

BMS-986165 prototype 1

Specified dose on specified days

Intervention Type DRUG

BMS-986165 prototype 2

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In the opinion of the investigator, a healthy participant is determined by having no clinically significant deviation from normal in medical history, physical examination,electrocardiograms, vital signs, and clinical laboratory determinations.
* Body weight \>= 50 kg at screening
* Women and men must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

* Any major surgery, per investigator's discretion, within 4 weeks of study drug administration
* Inability to tolerate oral medication
* History of allergy to BMS-986165 or related compounds
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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Quotient Sciences Miami

Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM011-096

Identifier Type: -

Identifier Source: org_study_id

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