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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Methotrexate, Leucovorin and BMS-986142; Drug: Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142

• Registration Number: NCT02456844
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-05-29
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

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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,.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Methotrexate, Leucovorin and BMS-986142	Methotrexate,Leucovorin and BMS-986142
Group 1	Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142	Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Days 1 through 10
Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T)	Days 1 through 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF)	Days 1 through 10

Secondary Outcome Measures

Name	Time	Method
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight	Days 1 through 10
Apparent total body clearance (parents only), CLT/F	Days 1 through 10
Time of maximum observed plasma concentration (Tmax)	Days 1 through 10
Terminal plasma half-life (T-half)	Days 1 through 10
Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight	Days 1 through 10
Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight	Days 1 through 10
Trough observed plasma concentration (For BMS-986142 only)	Days 1 through 10