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A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects

NCT ID: NCT03346837

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-22

Study Completion Date

2017-12-20

Brief Summary

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Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.

Detailed Description

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A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.

Conditions

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Malignancies Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Inhibition (Cohort 1)

Single oral dose BMS-986205

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

BMS-986205

Inhibition (Cohort 2)

Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

BMS-986205

Itraconazole

Intervention Type DRUG

Oral solution

Induction (Cohort 3)

Single oral dose BMS-986205

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

BMS-986205

Induction (Cohort 4)

Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8

Group Type EXPERIMENTAL

BMS-986205

Intervention Type DRUG

BMS-986205

Rifampin

Intervention Type DRUG

Tablet

Interventions

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BMS-986205

BMS-986205

Intervention Type DRUG

Itraconazole

Oral solution

Intervention Type DRUG

Rifampin

Tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body mass index 18.0 to 32.0 kg/m2, inclusive
* Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
* Women must not be of childbearing potential (cannot become pregnant)

Exclusion Criteria

* Any significant acute or chronic medical illness
* History of glucose-6-phosphodiesterase (G6PD) deficiency
* Personal or family history of cytochrome b5 reductase deficiency
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

Briston-Myers Squibb

Locations

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PPD

Austin, Texas, United States

Site Status

Countries

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United States

Related Links

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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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CA017-051

Identifier Type: -

Identifier Source: org_study_id