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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT03312426

Collaborator

(none)

Enrollment

Location

Arms

1.4

Actual Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: BMS-986205	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 9, 2017

Actual Primary Completion Date :

Nov 22, 2017

Actual Study Completion Date :

Nov 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BMS-986205 under fasted conditions then with high-fat meal. 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).	Drug: BMS-986205 Single dose, 100 mg administered at Day 1 and at Day 15.
Experimental: BMS-986205 with high-fat meal then under fasted conditions. 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).	Drug: BMS-986205 Single dose, 100 mg administered at Day 1 and at Day 15.
Experimental: BMS-986205 under fasted conditions then with light meal. 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).	Drug: BMS-986205 Single dose, 100 mg administered at Day 1 and at Day 15.
Experimental: BMS-986205 with light meal then under fasted conditions. 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).	Drug: BMS-986205 Single dose, 100 mg administered at Day 1 and at Day 15.

Outcome Measures

Primary Outcome Measures

Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal. [Up to 21 days]
Measured by plasma concentration.
Area under the plasma concentration-time curve from time zero to 168 hours (AUC[0-168]) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal. [Up to 21 days]
Measured by plasma concentration.
Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal. [Up to 21 days]
Measured by plasma concentration.
AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal. [Up to 21 days]
Measured by plasma concentration.

Secondary Outcome Measures

Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) following administration of single, 100 mg tablet of BMS-986205 under fasting conditions, with a light meal or with a high-fat meal. [Day 1 up to Day 22]
Safety and tolerability of BMS-986205 measured by investigator assessment.
Results of clinical laboratory tests [Up to 22 days]
Measured by Investigator assessment
Results of vital sign measurements [Up to 22 days]
Measured by Investigator assessment
Results of electrocardiogram (ECG) [Up to 22 days]
Measured by Investigator Assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.