NCT01951053

A Study to Evaluate Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of JNJ-404118413 in Healthy Male Patients

A Blinded, Placebo- and Comparator-Controlled Three-way Crossover Study to Investigate the Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effect of JNJ-40411813 on rapid eye movement sleep and deep sleep; safety, tolerability and pharmacokinetics (what the body does to the study medication) of JNJ-40411813.

Detailed description

This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (effect of the study medication will be compared with the effect of placebo \[inactive substance\]), comparator-controlled (effect of the study medication will be compared with the effect of FDA approved and marketed active substance \[citalopram\]), and 3-way crossover (method used to switch participants from one treatment arm to another treatment arm) study. This study will be double-blinded for treatment with placebo and JNJ-40411813; however, it will be open label (all people know the identity of the intervention) for treatment with citalopram. This study will consist of screening phase (within 28 days prior to the start of study medication), treatment phase, and follow-up phase (approximately 14 days after the last administration of study medication). Participants will be randomly assigned to 1 of 6 sequences (Sequences 1, 2, 3, 4, 5, and 6) to receive JNJ-40411813, citalopram, and placebo. Each sequence consists of 3 treatment periods (Period 1, Period 2, and Period 3) and each subsequent treatment period will be separated by a wash out period (no treatment) of at least 7 days. Approximately, 18 participants will be enrolled in this study (3 participants in each sequence). Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be evaluated throughout the study duration. The total duration of study participation for a participant will be approximately 10 Weeks.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-40411813	Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.
DRUG	Placebo	Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.
DRUG	Citalopram	Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2013-09-26
• Last updated: 2013-09-26

Locations

1 site across 1 country: Germany