NCT01986491

A Study of Solid Formulations of JNJ-39393406 in Healthy Male Participants

An Open-Label, Single Dose, Relative Bioavailability Study of Solid Formulations in Fed and Fasted Conditions Followed by a Repeated Dose Study of a Selected Solid Formulation of JNJ-39393406 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 compare the pharmacokinetics (what a medication does to the body), dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations in Part 1; based on the profile in Part 1, one of the formulations assessed will be selected to investigate the pharmacokinetics in fasting condition in Part 2 and after repeated dosing in Part 3.

Detailed description

This is an open-label (all people know the identity of the intervention) and single center study that will be conducted in 3 parts (Part 1, Part 2, and Part 3). The study consists of 3 phases including, the screening phase, treatment phase, and the follow-up phase. Part 1 is a four-way cross-over (method used to switch participants from one treatment arm to another in a clinical study) study to compare the pharmacokinetics, dose-proportionality, safety and tolerability of JNJ 39393406 following single dose oral administration of two solid oral formulations (X and Y). Approximately 12 participants will be enrolled in Part 1. Part 2 is two-way cross-over study in a separate group of participants to assess pharmacokinetics in fasting condition and the relative bioavailability (the extent to which a medication or other substance becomes available to the body) of the selected solid formulation from Part 1 compared with a solution formulation. Approximately 8 participants will be enrolled in Part 2. In Part 3, the single and repeated dose pharmacokinetics after administration of the selected formulation from Part 1 will be assessed for 7 consecutive days. The same participants will participate in Parts 2 and 3 of the study. Safety will be evaluated by the assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, and neurological examination. The duration of participation in the study for an individual participant will be approximately 8 weeks (including screening and follow up visit).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ 39393406 30 mg solid X	Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
DRUG	JNJ 39393406 30 mg solid Y	Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
DRUG	JNJ 39393406 120 mg solid X	Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
DRUG	JNJ 39393406 120 mg solid Y	Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
DRUG	JNJ 39393406 30 mg solution	Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2013-11-18
• Last updated: 2013-11-18

Locations

1 site across 1 country: Belgium