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This study will determine whether the plasma concentration-time profile and pharmacokinetics of MK4305 in patients with moderate and mild hepatic insufficiency are similar to those observed in healthy patients.
If there is no significant difference in the pharmacokinetics of MK4305 between healthy subjects and moderate hepatic insufficiency patients in Part I of the study, then the study will not continue into Part II.
Anticipated Sample Size:
32 (16 in each Part: 8 healthy and 8 patients)
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Published on BioPortfolio: 2014-08-27T03:16:52-0400
This study will establish the safety and tolerability of MK4305 when administered for up to 14 months.
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This study will investigate whether the plasma concentration-time profile and pharmacokinetics of MK4305 in patients with impaired renal function are similar to those observed in healthy s...
This is a multicenter study to test the hypothesis that MK4305 compared to placebo measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after...
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