Pharmacokinetics of MK4305 in Patients With Impaired Renal Function
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01059851
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:16:15-0400
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Medical and Biotech [MESH] Definitions
Insomnia, Fatal Familial
An autosomal dominant disorder characterized by degeneration of the THALAMUS and progressive insomnia. It is caused by a mutation in the prion protein (PRIONS).
Chloral Hydrate
A hypnotic and sedative used in the treatment of INSOMNIA.
Oxazepam
A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia.
Eszopiclone
A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.
Ethchlorvynol
A sedative and hypnotic that has been used in the short-term management of INSOMNIA. Its use has been superseded by other drugs.
