A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates
Status: | Recruiting |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 8/3/2016 |
Start Date: | May 2016 |
End Date: | August 2016 |
Contact: | Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: |
Email: | Clinical.Trials@bms.com |
Effects of Concomitant Administration of BMS-986142 on the Single-dose Pharmacokinetics of Probe Substrates for CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-gp in Healthy Subjects
The study is being conducted to assess the effect of BMS-986142 on the single-dose PK
parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for
(cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.
parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for
(cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.
Inclusion Criteria:
1. Signed Informed Consent
2. Target population: Healthy (current non-smokers) subjects as determined by medical
history, surgical history, physical examination, vital signs, electrocardiogram
(ECG), and clinical laboratory determinations.
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive
4. Men, and women of nonchildbearing potential. Women must have documented proof that
they are not of childbearing potential and must not be breastfeeding.
5. 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(s) plus 5 half-lives of the study drug (3 days) plus 90 days
(duration of sperm turnover) for a total of 93 days (approximately 14 weeks) after
treatment completion. Female partners of male subjects are expected to use one of the
highly effective methods of contraception listed in the protocol.
Exclusion Criteria:
1. History of any chronic or acute illness, recent infection, gastrointestinal disease,
smoking and alcohol abuse, any significant drug allergy or allergy to digoxin,
flurbiprofen, midazolam, omeprazole, or montelukast, Bruton's tyrosine kinase (BTK)
inhibitors, immunologic or related compounds.
2. History of billiary disorder, asthma, bleeding disorder, cancer
3. Received live vaccine during last 12 weeks, active tuberculosis (TB) in last 3 years
4. Medical history indicative of an increased risk of arrhythmia.
5. Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations beyond
what is consistent with the target population.
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