NCT01114126

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

Randomized, Double-blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of Neu-P11 in Subjects With Primary Insomnia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Neurim Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The effects of four multiple ascending doses of orally administered Neu-P11 will be evaluated in a double- blind, placebo-controlled, crossover design. Following a screening visit, the recruited subjects will undergo an inclusion/habituation full night PSG screening recording in the sleep clinic to exclude subjects with sleep disorders. Eligible subjects will be divided into 2 cohorts of 12 subjects each. Following screening, each cohort will be randomised to receive Neu-P11 or placebo for a first period of 5 days and will be crossed over following at least 21 days to receive placebo or a higher dose of Neu-P11 for a second period of 5 days. Each cohort will receive a different dose of Neu-P11, chosen from 2, 5, 20 and 50 mg. The starting dose is 5 mg but a smaller dose (2 mg) is also included for the purpose of pharmacodynamic evaluation. Before proceeding from 5mg to the next higher dose safety will be evaluated based on adverse events, clinical and biological data. Subjects of Cohort A will be randomised to dose levels 2 and 3 (doses 5 and 20 mg). Subjects of Cohort B will be randomised to dose levels 1 and 4 (doses 2 and 50 mg).

Conditions

• Insomnia

Interventions

Type	Name	Description
DRUG	Neu-P11	comparison of different dosages of drug
DRUG	Neu-P11 placebo	comparison of different dosages

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2011-04-01
• First posted: 2010-04-30
• Last updated: 2011-04-07

Locations

1 site across 1 country: France