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Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165

NCT ID: NCT03930602

Last Updated: 2021-11-17

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

2019-05-01

Study Completion Date

2019-05-27

Brief Summary

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To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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BMS-986165+Fluvoxamine

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Participants will receive BMS-986165.

Fluvoxamine

Intervention Type DRUG

Participants will receive fluvoxamine.

BMS-986165 only

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Participants will receive BMS-986165.

Fluvoxamine only

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

Participants will receive fluvoxamine.

Interventions

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BMS-986165

Participants will receive BMS-986165.

Intervention Type DRUG

Fluvoxamine

Participants will receive fluvoxamine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
* Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
* Any major surgery within 4 weeks of study drug administration
* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
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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ICON Plc (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/clinical-trials-and-research.html

Investigator Inquiry Form

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

FDA Safety Alerts and Recalls

Other Identifiers

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IM011-088

Identifier Type: -

Identifier Source: org_study_id