Rheumatoid Arthritis Clinical Trial
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
| Verified date | December 2017 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | November 10, 2017 |
| Est. primary completion date | November 5, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | PPD Development, LP | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Measured by plasma concentrations | Up to 26 days | |
| Primary | Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) | Measured by plasma concentrations | Up to 26 days | |
| Primary | Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Measured by plasma concentrations | Up to 26 days | |
| Secondary | Number of participants with adverse events | Measured by investigator assessment | Up to 28 days | |
| Secondary | Number of participants with serious adverse events | Measured by investigator assessment | Up to 45 days | |
| Secondary | Number of participants with adverse events leading to discontinuation | Measured by investigator assessment | Up to 28 days | |
| Secondary | Number of participants with clinical laboratory test abnormalities | Up to 28 days | ||
| Secondary | Number of participants with vital sign measurement abnormalities | Up to 28 days | ||
| Secondary | Number of participants with electrocardiogram abnormalities | Up to 28 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 28 days | ||
| Secondary | Number of participants with marked abnormalities in clinical laboratory test results | Up to 28 days |
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