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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986205

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Austin Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.	Measured by plasma concentration.	Up to 21 days
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.	Measured by plasma concentration.	Up to 21 days
Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.	Measured by plasma concentration.	Up to 21 days
AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal.	Measured by plasma concentration.	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Safety and tolerability of BMS-986205 measured by investigator assessment.	Day 1 up to Day 22
Results of clinical laboratory tests	Measured by Investigator assessment	Up to 22 days
Results of vital sign measurements	Measured by Investigator assessment	Up to 22 days
Results of electrocardiogram (ECG)	Measured by Investigator Assessment	Up to 22 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): November 22, 2017
• Study Completion (Actual): November 22, 2017

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Healthy Subjects; Healthy Participants; Neoplasm; Tumor
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Linrodostat
• Other Study ID Numbers: CA017-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No