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A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

NCT ID: NCT03378310

Last Updated: 2018-02-28

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2018-02-22

Brief Summary

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This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.

Detailed Description

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Conditions

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Healthy Volunteers

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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Reference tablet followed by BMS-986205 tablet with free base

BMS-986205 reference tablet (treatment period 1) followed by BMS-986205 tablet with free base (treatment period 2).

Group Type EXPERIMENTAL

BMS-986205 reference tablet

Intervention Type DRUG

Single, 100 mg oral dose.

BMS-986205 tablet with free base

Intervention Type DRUG

Single, 100 mg oral dose.

BMS-986205 tablet with free base followed by reference tablet

BMS-986205 tablet with free base (treatment period 1) followed by BMS-986205 reference tablet (treatment period 2).

Group Type EXPERIMENTAL

BMS-986205 reference tablet

Intervention Type DRUG

Single, 100 mg oral dose.

BMS-986205 tablet with free base

Intervention Type DRUG

Single, 100 mg oral dose.

Interventions

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BMS-986205 reference tablet

Single, 100 mg oral dose.

Intervention Type DRUG

BMS-986205 tablet with free base

Single, 100 mg oral dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed, written informed consent.
* Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
* Normal renal (kidney) function.
* Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
* Women must have documented proof they are not of childbearing potential.
* Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion Criteria

* Women of childbearing potential or breastfeeding.
* Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
* History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
* Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
* Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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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PPD Austin Clinic

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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

FDA Safety Alerts and Recalls

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

Investigator Inquiry Form

Other Identifiers

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CA017-069

Identifier Type: -

Identifier Source: org_study_id