Thrombosis
Conditions
Brief summary
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
Interventions
DRUGBMS-986177
Single oral dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177 | Up to 5 days |
| Maximum observed plasma concentration (Cmax) of BMS-986177 | Up to 5 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-987177 | Up to 5 days |
| Area under the plasma concentration-time curve from time zero to the time the last quantifiable concentration (AUC(0-T)) of BMS-986177 | Up to 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation | Screening until 30 days after discontinuation of dosing or subject's participation |
| Number of participants with clinical laboratory abnormalities | Screening until 30 days after discontinuation of dosing or subject's participation |
| Number of participants with clinically significant changes in electrical activity of the heart measured by electrocardiogram (ECG) | Screening until 30 days after discontinuation of dosing or subject's participation |
| Number of participants with vital sign abnormalities | Screening until 30 days after discontinuation of dosing or subject's participation |
Countries
United States
Outcome results
None listed