Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mild Hepatic Subjects Subjects are given a single dose of BMS-986177 |
Drug: BMS-986177
Single oral dose
|
| Experimental: Moderate Hepatic Subjects Subjects are given a single dose of BMS-986177 |
Drug: BMS-986177
Single oral dose
|
| Experimental: Healthy Match Subjects Subjects are given a single dose of BMS-986177 |
Drug: BMS-986177
Single oral dose
|
Outcome Measures
Primary Outcome Measures
- 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]
- Area under the plasma concentration-time curve from time zero to (AUC(0-72)) of BMS-986177 [Up to 5 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Pharmacology of Miami | Miami | Florida | United States | 33014 |
| 2 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
| 3 | Texas Liver Institute | San Antonio | Texas | United States | 78215 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV010-013