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Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

NCT ID: NCT03131973

Last Updated: 2017-12-15

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

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-13

Study Completion Date

2017-11-10

Brief Summary

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Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.

Detailed Description

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Conditions

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Rheumatoid Arthritis

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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Methotrexate

Methotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days

Group Type EXPERIMENTAL

BMS-986195

Intervention Type DRUG

Specified dose on specified days

Methotrexate

Intervention Type DRUG

Specified dose on specified days

Leucovorin

Intervention Type DRUG

Specified dose on specified days

Cytochrome P450 and Transporter Substrates

Caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days.

Group Type EXPERIMENTAL

BMS-986195

Intervention Type DRUG

Specified dose on specified days

Caffeine

Intervention Type DRUG

Specified dose on specified days

Montelukast

Intervention Type DRUG

Specified dose on specified days

Flurbiprofen

Intervention Type DRUG

Specified dose on specified days

Omeprazole

Intervention Type DRUG

Specified dose on specified days

Midazolam

Intervention Type DRUG

Specified dose on specified days

Digoxin

Intervention Type DRUG

Specified dose on specified days

Pravastatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986195

Specified dose on specified days

Intervention Type DRUG

Methotrexate

Specified dose on specified days

Intervention Type DRUG

Leucovorin

Specified dose on specified days

Intervention Type DRUG

Caffeine

Specified dose on specified days

Intervention Type DRUG

Montelukast

Specified dose on specified days

Intervention Type DRUG

Flurbiprofen

Specified dose on specified days

Intervention Type DRUG

Omeprazole

Specified dose on specified days

Intervention Type DRUG

Midazolam

Specified dose on specified days

Intervention Type DRUG

Digoxin

Specified dose on specified days

Intervention Type DRUG

Pravastatin

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments
* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
* Normal kidney function at screening

Exclusion Criteria

* History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months
* History of headaches related to caffeine withdrawal, including energy drinks
* History of syncope, orthostatic instability, or recurrent dizziness
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 Development, LP

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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IM014-013

Identifier Type: -

Identifier Source: org_study_id