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Completed

NCT Number: NCT03312426

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Austin Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986205

Drug

Single dose, 100 mg administered at Day 1 and at Day 15.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) following administration of single, 100 mg tablet of BMS-986205 with a high-fat meal.

    Time frame: Up to 21 days

    Measured by plasma concentration.

  2. 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.

    Time frame: Up to 21 days

    Measured by plasma concentration.

  3. Cmax following administration of single, 100 mg tablet of BMS-986205 with a light meal.

    Time frame: Up to 21 days

    Measured by plasma concentration.

  4. AUC(0-168) following administration of single, 100 mg tablet of BMS-986205 with a light meal.

    Time frame: Up to 21 days

    Measured by plasma concentration.

Secondary outcomes

  1. 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.

    Time frame: Day 1 up to Day 22

    Safety and tolerability of BMS-986205 measured by investigator assessment.

  2. Results of clinical laboratory tests

    Time frame: Up to 22 days

    Measured by Investigator assessment

  3. Results of vital sign measurements

    Time frame: Up to 22 days

    Measured by Investigator assessment

  4. Results of electrocardiogram (ECG)

    Time frame: Up to 22 days

    Measured by Investigator Assessment

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2017
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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