NCT02230878

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-42847922 in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety, tolerability, pharmacokinetic (the study of the way a drug enters and leaves the blood and tissues over time), dose-proportionality, accumulation, urinary excretion, pharmacodynamics (the study of how drugs act on the body) and sedative effects of JNJ-42847922 in healthy male and female participants.

Detailed description

This is a Phase 1, double blind (a medical research study in which neither the researchers nor the participants know what treatment the participants is receiving), randomized (study drug assigned by chance), placebo controlled, multiple ascending dose study. The study will consist of 3 parts: a Screening period (Days -21 to -2), a Double-blind treatment period (Day -1 to Day 11), and a Follow-up period (within 7 to 14 days after last dose administration). In double blind treatment period, participants will be randomly assigned to 5, 10, 20, and 40 milligram (mg) or placebo. Number of participants with any clinically relevant changes (adverse events \[AEs\], laboratory results,electrocardiogram \[ECG\], Vital signs, Physical and neurological, sedation \& concentration) and columbia suicide severity rating (CSSR) scale will be evaluated as primary outcome measure. Participants' safety will be monitored throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-42847922 5 mg	Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.
DRUG	JNJ-42847922 10 mg	Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.
DRUG	JNJ-42847922 20 mg	Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.
DRUG	JNJ-42847922 40 mg	Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .
DRUG	Placebo	Participants will receive matching placebo from Day 1 up to Day 10.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-09-03
• Last updated: 2017-01-24

Locations

1 site across 1 country: Germany