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Completed

NCT Number: NCT03378310

A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet

This is a Phase 1, open-label, randomized study in healthy participants to evaluate the absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet. Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the clinical facility for the duration of the study.

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Key information

Conditions

Healthy Volunteers

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 informed consent.
  • Healthy male and female participants (not of childbearing potential), determined by medical history, physical examination, electrocardiograms (ECGs) and clinical laboratory tests.
  • Normal renal (kidney) function.
  • Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive.
  • Women must have documented proof they are not of childbearing potential.
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment and 110 days after the last dose of BMS-986205. In addition, male participants must be willing to refrain from sperm donation during this time.

Exclusion criteria

  • Women of childbearing potential or breastfeeding.
  • Active tuberculosis (TB) requiring treatment or documented latent TB within the previous 3 years. Also excluded are participants with evidence of a past TB infection without documented adequate therapy.
  • History of pulmonary, renal, or liver disease; or of cardiac arrhythmias.
  • Recent (within 6 months of study drug administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
  • Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).

Other protocol defined inclusion/exclusion criteria could apply.

Treatment and study plan

BMS-986205 reference tablet

Drug

Single, 100 mg oral dose.

BMS-986205 tablet with free base

Drug

Single, 100 mg oral dose.

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986205 tablet with free base compared to reference tablet.

    Time frame: Up to Day 22

    Measured by plasma concentration.

  2. Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of BMS-986205 tablet with free base compared to reference tablet.

    Time frame: Up to Day 22

    Measured by plasma concentration.

Secondary outcomes

  1. Incidence of non-serious Adverse Events (AEs).

    Time frame: Up to Day 22

    Safety and tolerability as measured by incidence of non-serious AEs.

  2. Incidence of Serious Adverse Events (SAEs).

    Time frame: Up to Day 22

    Safety and tolerability as measured by incidence of SAEs.

  3. Incidence of Adverse Events (AEs) leading to discontinuation.

    Time frame: Up to Day 22

    Safety and tolerability as measured by incidence of AEs leading to discontinuation.

  4. Number of participants with vital sign abnormalities.

    Time frame: Up to Day 22

  5. Number of participants with electrocardiogram (ECG) abnormalities.

    Time frame: Up to Day 22

  6. Number of participants with clinical laboratory abnormalities.

    Time frame: Up to Day 22

  7. Number of participants with physical examination abnormalities.

    Time frame: Up to Day 22

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Open-Label Study to Evaluate the Bioavailability of a BMS-986205 Tablet Containing Free Base Relative to a Reference Tablet in Healthy Participants

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 19, 2017
Registry last updated
Feb 28, 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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