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OpenTrials
Completed

NCT Number: NCT03131973

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.

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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

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female (not of childbearing potential) participants as determined by medical and surgical history and assessments
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive
  • Normal kidney function at screening

Exclusion criteria

  • History of chronic headaches (eg, migraines, cluster headaches), defined as occurring 15 days or more a month, over the previous 3 months
  • History of headaches related to caffeine withdrawal, including energy drinks
  • History of syncope, orthostatic instability, or recurrent dizziness

Other protocol defined inclusion and exclusion criteria could apply

Treatment and study plan

BMS-986195

Drug

Specified dose on specified days

methotrexate

Drug

Specified dose on specified days

Leucovorin

Drug

Specified dose on specified days

Caffeine

Drug

Specified dose on specified days

Montelukast

Drug

Specified dose on specified days

Flurbiprofen

Drug

Specified dose on specified days

Omeprazole

Drug

Specified dose on specified days

midazolam

Drug

Specified dose on specified days

Digoxin

Drug

Specified dose on specified days

Pravastatin

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 26 days

    Measured by plasma concentrations

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

    Time frame: Up to 26 days

    Measured by plasma concentrations

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

    Time frame: Up to 26 days

    Measured by plasma concentrations

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Up to 28 days

    Measured by investigator assessment

  2. Number of participants with serious adverse events

    Time frame: Up to 45 days

    Measured by investigator assessment

  3. Number of participants with adverse events leading to discontinuation

    Time frame: Up to 28 days

    Measured by investigator assessment

  4. Number of participants with clinical laboratory test abnormalities

    Time frame: Up to 28 days

  5. Number of participants with vital sign measurement abnormalities

    Time frame: Up to 28 days

  6. Number of participants with electrocardiogram abnormalities

    Time frame: Up to 28 days

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 28 days

  8. Number of participants with marked abnormalities in clinical laboratory test results

    Time frame: Up to 28 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Effects of Concomitant Administration of BMS-986195 on the Single-dose Pharmacokinetics of Methotrexate and Probe Substrates for Cytochrome P450 1A2, 2C8, 2C9, 2C19, 3A4, Organic Anion Transporter Polypeptide 1B1 and P-glycoprotein in Healthy Participants

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2017
Registry last updated
Dec 15, 2017

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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