Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 11/16/2018 |
Start Date: | March 1, 2018 |
End Date: | September 28, 2018 |
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
moderate hepatic impairment and healthy matched subjects to evaluate pharmacokinetics,
safety, and tolerability in these subjects
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
We found this trial at
3
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
Orlando, Florida 32806
407-240-7878
Principal Investigator: Thomas Marbury, MD
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Miami, Florida 33014
Principal Investigator: Kenneth Lasseter
Phone: 305-817-2900
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