A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT02762123
• Date of registration: 03/05/2016
• Prospective Registration: No
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates
• Scientific title: 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
• Date of first enrolment: May 2016
• Target sample size: 28
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02762123
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin)

Drug: BMS-986142 200mg

Drug: BMS-986142 350mg

Primary Outcome(s)

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin [Time Frame: 57 samples up to day 26]

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin [Time Frame: 57 samples up to day 26]

Maximum observed plasma concentration (Cmax) of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin. [Time Frame: 57 samples up to day 26]

Secondary Outcome(s)

Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death [Time Frame: Days 1-26; for SAEs up to 30 days post discontinuation of dosing]

Secondary ID(s)

IM006-031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors