Overview

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

Status:
Completed

Trial end date:
2015-07-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Bristol-Myers Squibb

Treatments:

Digoxin
Flurbiprofen
Leucovorin
Methotrexate
Midazolam
Montelukast
Pravastatin

Criteria

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,.