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
Insomnia
MK4305
Merck Sharp & Dohme IDEA, Inc.
Moscow
Russian Federation
121059
Recruiting
Merck
Published on BioPortfolio: 2014-08-27T03:16:15-0400
A Long Term Safety Study of MK4305 in Patients With Primary Insomnia
This study will establish the safety and tolerability of MK4305 when administered for up to 14 months.
Pharmacokinetics of MK4305 in Patients With Hepatic Insufficiency
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...
Safety and Efficacy Study in Primary Insomnia Patients- Study A
This is a multicenter study to test the hypothesis that MK4305 is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to ...
Safety and Efficacy Study in Primary Insomnia Patients-Study B
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...
Self-help Cognitive Behavioral Therapy (CBT) for Insomnia
The purpose of this study is to investigate whether a self-help book for insomnia, with or without therapist support, can improve sleep and alleviate insomnia symptoms in individuals suffe...
Familial risk for insomnia is associated with abnormal cortisol response to stress.
Abnormalities in the stress system have been implicated in insomnia. However, studies examining physiological stress regulation in insomnia have not consistently detected differences in the hypothalam...
The prevalence of insomnia ranges from 36% to 91% in alcohol-dependent patients and may persist after alcohol withdrawal. Acamprosate has been shown to decrease insomnia in abstinent patients. Based o...
Insomnia is a common sleep disorder that is associated with a range of adverse outcomes. Patients with insomnia exhibit hyperarousal in multiple domains, including an elevated metabolic rate, but spec...
Factors associated with insomnia in pregnancy: A prospective Cohort Study.
To quantify insomnia and their components in a longitudinal cohort of pregnant women and factors associated with insomnia.
Psychological processes associated with insomnia in patients with multiple sclerosis.
Despite the high comorbidity of insomnia disorder (ID) with multiple sclerosis (MS), the relevance of psychological processes involved in the maintenance of insomnia is yet to be established in this n...
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.