An Investigational Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Absorption of BMS-986205 in Healthy Participants
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/21/2018 |
| Start Date: | October 9, 2017 |
| End Date: | November 22, 2017 |
Randomized, Open-Label Study to Assess the Effect of a Light Meal and a High-Fat Meal on the Bioavailability of a Single 100-mg Dose of BMS-986205 Commercial Tablet in Healthy Participants
The purpose of this study is to investigate the effect of a light meal and a high-fat meal on
the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants.
Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat
meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of
the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions
will be assessed.
the bioavailability (absorption) of of BMS-986205 commercial tablet in healthy participants.
Eligible participants will receive a single dose of BMS-986205 under fasted or fed (high-fat
meal or light meal) conditions on Day 1 and Day 15. The safety, tolerability and movement of
the BMS-986205 into, through and out of the body (pharmacokinetics/PK) under these conditions
will be assessed.
Inclusion Criteria:
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no
clinically significant deviation from normal in medical history, physical examination,
ECGs (electrocardiograms), and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow
instructions for method(s) of contraception for duration of treatment with BMS-986205,
and for a total of 110 days after the last dose of BMS-986205; and must be willing to
refrain from sperm donation during this time. Azoospermic males are exempt from
contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.
Exclusion Criteria:
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- Active tuberculosis (TB) requiring treatment, documented latent TB within the previous
3 years, or evidence of a past TB infection without documented adequate therapy. All
participants will be required to have a QuantiFERON-TB Gold test performed at
screening.
- History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital
hemolytic anemias.
- History of cardiac arrhythmias and/or autonomic instability.
- History of pulmonary, renal or liver disease.
- History of Gilbert's Syndrome.
- Recent (within 6 months of study drug administration) history of smoking or current
smokers, including use of electronic cigarettes or nicotine-containing products such
as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
- Participants with active, known or suspected autoimmune disease. Participants with
vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to
recur in the absence of an external trigger may enroll.
- Major surgery within 4 weeks of study drug administration.
Other protocol defined inclusion/exclusion criteria could apply.
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