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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 subjects; and will evaluate the safety and tolerability of MK4305 both in patients with impaired renal function and in healthy subjects.
If preliminary data from Part I confirms that renal impairment does not alter the pharmacokinetics of MK4305 to the extent that would require a dosage adjustment, then no further study will be required. If the data does not support this conclusion, then Part II will be conducted.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Merck Sharp & Dohme IDEA, Inc.
Published on BioPortfolio: 2014-08-27T03:16:15-0400
This study will establish the safety and tolerability of MK4305 when administered for up to 14 months.
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 observe...
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