NCT01965301

First-time-in-man, to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375

Double-blind, Placebo Controlled, Randomized Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP1.5375 After Single Oral Administrations Ranging From 0.5 mg to 100 mg 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).

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Bioprojet · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	BP1.5375 suspension	single oral dose
DRUG	Diphenhydramine	single oral dose of Diphenhydramine 50mg
DRUG	Placebo	Single oral dose

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2013-10-18
• Last updated: 2015-01-21

Locations

1 site across 1 country: Netherlands