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

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-07-31

Brief Summary

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

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Group 2

Methotrexate,Leucovorin and BMS-986142

Group Type EXPERIMENTAL

Methotrexate, Leucovorin and BMS-986142

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Groups 1 and 2:

1. Written informed consent from all subjects.
2. Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
3. Non-smokers.
4. Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of \> 90 mL/min/1.73 m2 .
5. Subject reenrollment.
6. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of BMS-986142.
7. Male subjects must be willing to refrain from sperm donation during the entire study plus 5 half-lives of BMS-986142.

Group 1 only:

1. Healthy male and female (not of childbearing potential) subjects as determined by medical history, and clinical assessments.
2. Women must have documented proof that they are not of childbearing potential and must not be breast feeding.

Group 2 only:

1\. Healthy male subjects as determined by medical history, and clinical assessments.

Exclusion Criteria

1. Administration of live vaccine including polio vaccine during the course of the study, 12 weeks prior to the first dose of study drug, or 30 days after the last dose of study drug.
2. Active tuberculosis (TB) requiring treatment within the previous 3 years.
3. History of herpes zoster.
4. Subjects who have experienced recent infection, upper respiratory infection,.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes