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Completed

NCT Number: NCT03374228

A Study to Evaluate the Bioavailability of BMS-986205

Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of [13C]BMS-986205 solution for intravenous administration in healthy participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, Ruddington Fields, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive
  • Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion criteria

  • Women who are of childbearing potential or breastfeeding
  • Any significant acute or chronic medical illness
  • Active tuberculosis (TB) requiring treatment or documented latent TB at screening

Other protocol defined inclusion / exclusion criteria could apply

Treatment and study plan

BMS-986205

Drug

Specified Dose on Specified Days

Primary outcomes

  1. Absolute oral bioavailability (F)

    Time frame: Up to 15 days

    Measured by plasma concentration

Secondary outcomes

  1. Occurrence of adverse events (AEs)

    Time frame: Up to 15 days

    Safety and tolerability as measured by incidence of AEs

  2. Occurrence of serious adverse events (SAEs)

    Time frame: Up to 15 days

    Safety and tolerability as measured by incidence of SAEs

  3. Occurrence of adverse events (AEs) leading to discontinuation

    Time frame: Up to 15 days

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

  4. Number of participants with vital sign measurement abnormalities

    Time frame: Up to 15 days

  5. Number of participants with electrocardiogram abnormalities

    Time frame: Up to 15 days

  6. Number of participants with physical examination abnormalities

    Time frame: Up to 15 days

  7. Number of participants with clinical laboratory test abnormalities

    Time frame: Up to 15 days

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Jun 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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