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

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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


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
407-240-7878
Principal Investigator: Thomas Marbury, MD
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Orlando, FL
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Miami, Florida 33014
Principal Investigator: Kenneth Lasseter
Phone: 305-817-2900
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Miami, FL
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San Antonio, Texas 78215
Principal Investigator: Eric Lawitz
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San Antonio, TX
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