Status:
COMPLETED
A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Chronic Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the pharmacokinetics (PK) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volu...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria for Healthy Participants Groups:
- Must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures.
- Key Inclusion Criteria for Hepatic Impaired Groups:
- Must have mild or moderate hepatic impairment.
- Must have a diagnosis of chronic liver disease for \>6 months.
- Clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor.
- Must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation.
- Key Exclusion Criteria
- Must not be on any prohibited medications for entry into the trial.
Exclusion
Key Trial Info
Start Date :
November 10 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01465412
Start Date
November 10 2011
End Date
June 14 2012
Last Update
September 24 2018
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