Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia
Status:
Completed
Trial end date:
2011-04-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the safety and tolerability of Neu-P11,
following the administration of multiple ascending oral doses (2, 5, 20, 50 mg or matching
placebo) given nightly over 2 periods of 5 days to male and female subjects with primary
insomnia. In addition, the study is aimed to determine the pharmacokinetic profile of Neu-P11
after 1 and 5 days of administration and to evaluate the hypnotic effects of Neu-P11 as well
as the effects on mood and memory. The study hypothesis is that Neu-P11 is safe, tolerated
and have significant sleep promoting effects.