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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312426
• Other study ID #: CA017-053
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2017
• Last updated: January 17, 2018
• Start date: October 9, 2017
• Est. completion date: November 22, 2017

Study information

• Verified date: January 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 22, 2017
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• BMS-986205
Single dose, 100 mg administered at Day 1 and at Day 15.

Locations

Country	Name	City	State
United States	PPD Austin Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.	Measured by plasma concentration.	Up to 21 days
Primary	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	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
Secondary	Results of clinical laboratory tests	Measured by Investigator assessment	Up to 22 days
Secondary	Results of vital sign measurements	Measured by Investigator assessment	Up to 22 days
Secondary	Results of electrocardiogram (ECG)	Measured by Investigator Assessment	Up to 22 days

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form