Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
Completed · Phase 1
Conditions studied: Thrombosis
In brief
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
Key facts
- Study ID
- NCT02982707
- Run by
- Bristol-Myers Squibb
- People needed
- 26
- Starts
- 2018-03-01
- Expected to finish
- 2018-09-28
- Last updated by the study team
- 2018-11-14
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Pharmacology of Miami — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Texas Liver Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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