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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BMS-986195

Methotrexate

Leucovorin

Caffeine

Montelukast

Flurbiprofen

Omeprazole

Midazolam

Digoxin

Pravastatin

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Other protocol defined inclusion and exclusion criteria could apply

Sites / Locations

PPD Development, LP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Methotrexate

Cytochrome P450 and Transporter Substrates

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Maximum observed plasma concentration (Cmax)

Measured by plasma concentrations

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

Measured by plasma concentrations

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

Measured by plasma concentrations

Secondary Outcome Measures

Number of participants with adverse events

Measured by investigator assessment

Number of participants with serious adverse events

Measured by investigator assessment

Number of participants with adverse events leading to discontinuation

Measured by investigator assessment

Number of participants with clinical laboratory test abnormalities

Number of participants with vital sign measurement abnormalities

Number of participants with electrocardiogram abnormalities

Number of participants with physical examination abnormalities

Number of participants with marked abnormalities in clinical laboratory test results

Full Information

NCT ID

NCT03131973

First Posted

April 25, 2017

Last Updated

December 13, 2017

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT03131973

Brief Title

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

Official Title

Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

May 13, 2017 (Actual)

Primary Completion Date

November 5, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methotrexate

Arm Type

Experimental

Arm Description

Arm Title

Cytochrome P450 and Transporter Substrates

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

BMS-986195

Intervention Description