NCT02812251

Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Participants

A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-61393215 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 versus placebo after single oral dose administration under fasted (ascending dose levels) and fed condition, to characterize the pharmacokinetics of JNJ-61393125 in plasma, cerebrospinal fluid (CSF) and urine after single oral dose administration and to investigate the effect of food (high fat/high calorie) on the pharmacokinetics of JNJ-61393215 following single oral dose administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-61393215	JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.
DRUG	Placebo	Matching placebo will be administered.

Timeline

• Start date: 2016-07-07
• Primary completion: 2016-11-17
• Completion: 2016-11-17
• First posted: 2016-06-24
• Last updated: 2025-04-27

Locations

1 site across 1 country: Netherlands