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OpenTrials
Completed

NCT Number: NCT03362437

Evaluate the Pharmacokinetics of BMS-986177 From Two Formulations in Healthy Participants

Assess the pharmacokinetics (fasting and fed), safety, and tolerability of BMS-986177 following oral dosing of Form A and Form B

Completed

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Ruddington, Nottingham, 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 18.0 to 32.0 kg/m2, inclusive
  • Women must not be of childbearing potential (cannot become pregnant)

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Head injury in the last 2 years
  • History of bleeding disorder including rectal bleeding (ie, hemorrhoids), spontaneous nosebleeds, etc.

Other protocol defined inclusion / exclusion criteria could apply

Treatment and study plan

BMS-986177

Drug

Form A

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 3 days

    Measured by plasma concentration

  2. AUC from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to 3 days

    Measured by plasma concentration

  3. AUC from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to 3 days

    Measured by plasma concentration

Secondary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 12 days

    Safety and tolerability as measured by incidence of AEs

  2. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 30 days

    Safety and tolerability as measured by incidence of SAEs

  3. Number of participants with electrocardiogram abnormalities

    Time frame: Up to 12 days

  4. Number of participants with physical examination abnormalities

    Time frame: Up to 12 days

  5. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 12 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics of BMS-986177 From Form A and Form B in Healthy Participants

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2017
Registry last updated
Mar 14, 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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