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Clinical Trial Summary

Phase I Single Ascending Dose (Part 1), phase IIa Proof Of Concept (Part 2)


Clinical Trial Description

This is a single center, Double-blind, placebo controlled, randomized study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BP1.5375 after single oral administrations ranging in healthy male subjects (Part 1) followed by the assessment of the effect of 3 single different BP1.5375 oral doses on polysomnography in comparison to 50 mg diphenhydramine and placebo in healthy male subjects (Part 2). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


NCT number NCT01965301
Study type Interventional
Source Bioprojet
Contact
Status Terminated
Phase Phase 1
Start date October 2014
Completion date December 2014

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