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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01465412 |
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Date of registration:
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28/10/2011 |
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Primary sponsor: |
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Public title:
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A Study to Assess Pharmacokinetics of Preladenant in Participants With Chronic Hepatic Impairment (P06513)
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Scientific title:
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An Open-label, Single Dose, Oral Administration, Sequential Two Parts Study to Compare the Pharmacokinetics of SCH 420814 / MK-3814 in Subjects With Mild and Moderate Chronic Hepatic Impairment With Their Respectively Matching Healthy Volunteers |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01465412 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria for Healthy Subjects 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Hepatic Impairment
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Intervention(s)
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Drug: Preladenant
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Primary Outcome(s)
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Area Under the Plasma Concentration-time curve from time 0 extrapolated to infinity (AUC[0-infinity]) after a single dose of preladenant
[Time Frame: Up to 4 Days]
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Secondary ID(s)
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MK-3814-034
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P06513
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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