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OpenTrials
Completed

NCT Number: NCT02982707

Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants

A single oral dose of BMS-986177 administered to subjects of mild hepatic impairment, moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics, safety, and tolerability in these subjects

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Key information

Conditions

Thrombosis Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women not of childbearing potential (WNOCBP) and males. Women must have documented proof they are not of childbearing potential
  • BMI of 20.0 to 38.0 kg/m2, inclusive
  • Hepatic subjects classified as Child-Pugh mild (Class A) or Child-Pugh moderate (Class B) who have had no significant change to disease status in past 6 months and are on stable treatment regimen
  • Healthy subjects must not have clinically significant deviations from normal in medical history, physical exam, ECGs, vital signs or clinical lab values

Exclusion criteria

  • Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation
  • Use of corticosteroids, nonsteroidal anti-inflammatory compounds, aspirin or other antiplatelet agents or anticoagulants within 2 weeks of dosing
  • Healthy subjects must not have used tobacco or have a history of drug or alcohol abuse within the last 6 months
  • Subjects must not have a current or recent (within 3 months) GI disease that increases participant risk of GI bleeding or interferes with absorption of the study drug

Other protocol defined inclusion and exclusion criteria may apply

Treatment and study plan

BMS-986177

Drug

Single oral dose

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of BMS-986177

    Time frame: Up to 5 days

  2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177

    Time frame: Up to 5 days

  3. Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177

    Time frame: Up to 5 days

  4. Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177

    Time frame: Up to 5 days

Secondary outcomes

  1. Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation

    Time frame: Screening until 30 days after discontinuation of dosing or subject's participation

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Screening until 30 days after discontinuation of dosing or subject's participation

  3. Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG)

    Time frame: Screening until 30 days after discontinuation of dosing or subject's participation

  4. Number of participants with vital sign abnormalities

    Time frame: Screening until 30 days after discontinuation of dosing or subject's participation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 5, 2016
Registry last updated
Nov 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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