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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline

Completed

Started May 2017

Shorter than P25 for phase_1 rheumatoid-arthritis

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

April 25, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed

16 days until next milestone

Study Start

First participant enrolled

May 13, 2017

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2017

Completed

5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed

Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

6 months

First QC Date

April 25, 2017

Last Update Submit

December 13, 2017

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

Maximum observed plasma concentration (Cmax)
Measured by plasma concentrations
Up to 26 days
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
Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentrations
Up to 26 days

Secondary Outcomes (8)

Number of participants with adverse events
Up to 28 days
Number of participants with serious adverse events
Up to 45 days
Number of participants with adverse events leading to discontinuation
Up to 28 days
Number of participants with clinical laboratory test abnormalities
Up to 28 days
Number of participants with vital sign measurement abnormalities
Up to 28 days
+3 more secondary outcomes

Study Arms (2)

Methotrexate

EXPERIMENTAL

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

Drug: BMS-986195Drug: MethotrexateDrug: Leucovorin

Cytochrome P450 and Transporter Substrates

EXPERIMENTAL

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.

Drug: BMS-986195Drug: CaffeineDrug: MontelukastDrug: FlurbiprofenDrug: OmeprazoleDrug: MidazolamDrug: DigoxinDrug: Pravastatin