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

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ClinicalTrials.gov Identifier: NCT03131973
Recruitment Status : Completed
First Posted : April 27, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BMS-986195 Drug: Methotrexate Drug: Leucovorin Drug: Caffeine Drug: Montelukast Drug: Flurbiprofen Drug: Omeprazole Drug: Midazolam Drug: Digoxin Drug: Pravastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : May 13, 2017
Actual Primary Completion Date : November 5, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Methotrexate
Methotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days
Drug: BMS-986195
Specified dose on specified days

Drug: Methotrexate
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Experimental: Cytochrome P450 and Transporter Substrates
Caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days.
Drug: BMS-986195
Specified dose on specified days

Drug: Caffeine
Specified dose on specified days

Drug: Montelukast
Specified dose on specified days

Drug: Flurbiprofen
Specified dose on specified days

Drug: Omeprazole
Specified dose on specified days

Drug: Midazolam
Specified dose on specified days

Drug: Digoxin
Specified dose on specified days

Drug: Pravastatin
Specified dose on specified days




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131973


Locations
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United States, Texas
PPD Development, LP
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03131973     History of Changes
Other Study ID Numbers: IM014-013
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Flurbiprofen
Methotrexate
Digoxin
Midazolam
Caffeine
Omeprazole
Pravastatin
Montelukast
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents