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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Methotrexate, Leucovorin and BMS-986142; Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456844

IM006-003

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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,.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

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

Group 2

Experimental group

Description:

Methotrexate,Leucovorin and BMS-986142

Treatment:

Drug: Methotrexate, Leucovorin and BMS-986142