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Completed

NCT Number: NCT02456844

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

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Groups 1 and 2:

  • Written informed consent from all subjects.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
  • Non-smokers.
  • Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 90 mL/min/1.73 m2 .
  • Subject reenrollment.
  • 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.
  • Male subjects must be willing to refrain from sperm donation during the entire study plus 5 half-lives of BMS-986142.

Group 1 only:

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

Group 2 only:

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

Exclusion criteria

  • 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.
  • Active tuberculosis (TB) requiring treatment within the previous 3 years.
  • History of herpes zoster.
  • Subjects who have experienced recent infection, upper respiratory infection,.

Treatment and study plan

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

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

Methotrexate, Leucovorin and BMS-986142

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

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Days 1 through 10

  2. Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration, AUC(0-T)

    Time frame: Days 1 through 10

  3. Area under the plasma concentration-time curve from time zero extrapolated to infinite time, AUC(INF)

    Time frame: Days 1 through 10

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Days 1 through 10

  2. Terminal plasma half-life (T-half)

    Time frame: Days 1 through 10

  3. Apparent total body clearance (parents only), CLT/F

    Time frame: Days 1 through 10

  4. Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight

    Time frame: Days 1 through 10

  5. Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight

    Time frame: Days 1 through 10

  6. Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight

    Time frame: Days 1 through 10

  7. Trough observed plasma concentration (For BMS-986142 only)

    Time frame: Days 1 through 10

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effects of BMS-986142 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates Montelukast (CYP2C8), Flurbiprofen (CYP2C9), Midazolam (CYP3A4), Digoxin (P-gp), and Pravastatin (OATP1B1) in Healthy Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 29, 2015
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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