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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03312426

Run by

Bristol-Myers Squibb

People needed

32

Starts

2017-10-09

Expected to finish

2017-11-22

Last updated by the study team

2018-01-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PPD Austin Clinic — Austin, Texas, United States

Full record on ClinicalTrials.gov

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