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Pharmacokinetics of MK4305 in Patients With Impaired Renal Function

2014-08-27 03:16:15 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Insomnia

Intervention

MK4305

Location

Merck Sharp & Dohme IDEA, Inc.
Moscow
Russian Federation
121059

Status

Recruiting

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:15-0400

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