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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986205

Study type: Interventional

Funder types: Industry

Identifiers

NCT03312426

CA017-053

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 4 patient groups

BMS-986205 under fasted conditions then with high-fat meal.

Experimental group

Description:

Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a high-fat meal (Day 15).

Treatment:

Drug: BMS-986205

BMS-986205 with high-fat meal then under fasted conditions.

Experimental group

Description:

Single, 100 mg dose of BMS-986205 with a high-fat meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).

Treatment:

Drug: BMS-986205

BMS-986205 under fasted conditions then with light meal.

Experimental group

Description:

Single, 100 mg dose of BMS-986205 under fasted conditions (Day 1) followed by single, 100 mg dose of BMS-986205 with a light meal (Day 15).

Treatment:

Drug: BMS-986205

BMS-986205 with light meal then under fasted conditions.

Experimental group

Description:

Single, 100 mg dose of BMS-986205 with a light meal (Day 1) followed by single, 100 mg dose of BMS-986205 under fasted conditions (Day 15).

Treatment:

Drug: BMS-986205