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Study to Investigate the Effect of BMS-986142 on the Pharmacokinetics (PK) of Methotrexate and Probe Substrate Cocktail in Healthy Patients

NCT02456844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-02-01

No results posted yet for this study

Summary

To study the Pharmacokinetics (PK) parameters of montelukast, flurbiprofen, midazolam, digoxin, pravastatin, and MTX when coadministered with BMS-986142.

Conditions

Interventions

DRUG

Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142

1. Montelukast 10-mg tablet: On Days 1 and 8,Single oral dose 2. Flurbiprofen 50-mg tablet: On Days 1 and 8,Single oral dose 3. Midazolam syrup 2.5 mL × 2 mg/mL (5 mg): On Days 1 and 8,Single oral dose 4. Digoxin (Lanoxin®) 0.25 mg tablet: On Days 1 and 8,Single oral dose 5. Pravastatin 40-mg tablet: On Days 1 and 8,Single oral dose 6. BMS-986142: On Days 6 through 12.

DRUG

Methotrexate, Leucovorin and BMS-986142

1. Methotrexate (MTX) single oral dose of 3 × 2.5-mg tablet (Days 1 and 8) 2. Leucovorin single oral dose of 15-mg tablet (Days 2 and 9; 24 hours after MTX administration) 3. BMS-986142 on Days 6 through 10.

Sponsors & Collaborators

Principal Investigators

  • Thomas L Hunt, MD PhD · PPD Development, LP

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456844 on ClinicalTrials.gov