Who is sponsoring NCT02218073?

NCT02218073 is sponsored by Janssen Research & Development, LLC.

What drugs are being tested in NCT02218073?

Interventions: JNJ-42756493 10 mg tablet, JNJ-42756493 10 mg Oral Solution, JNJ-61818549.

What is the status of NCT02218073?

NCT02218073 is currently COMPLETED.

Last reviewed 2015-01-07 · How we verify

A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of a Tablet Versus a Solution and to Assess the Absolute Bioavailability of Orally Administered JNJ-42756493 Following Concomitant Administration of an Intravenous Microdose of the Stable Isotope JNJ-61818549 in Healthy Subjects

NCT02218073 Phase 1 COMPLETED

The purpose of this study is to evaluate the absolute bioavailability (the extent to which a drug or other substance becomes available to the body) of JNJ-42756493 following a single 10 milligram (mg) dose as an oral solution administered in combination with a single intravenous administration of a microdose (100 microgram \[mcg\]) of JNJ-61818549 and to evaluate the relative bioavailability of 10 mg JNJ-42756493 following an oral solution (reference) and a tablet (test) formulation in a crossover (method used to switch subjects from one study group to another in a clinical trial) design in healthy participants.

Details

Lead sponsor	Janssen Research & Development, LLC
Phase	Phase 1
Status	COMPLETED
Enrolment	8
Start date	2014-10
Completion	2014-12

Conditions

Healthy

Interventions

JNJ-42756493 10 mg tablet
JNJ-42756493 10 mg Oral Solution
JNJ-61818549

Primary outcomes

Relative Bioavailability: Maximum Plasma Concentration (Cmax) — Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-42756493.
Absolute Bioavailability — Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Absolute bioavailability will be measured by Area under concentration time-curve (AUC \[0-24\]), AUC (0-last) and AUC (0-infinity).
Relative Bioavailability: Area under concententration time-curve (AUC) — Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose
Relative bioavailability will be measured by AUC (0-24), AUC (0-last) and AUC (0-infinity).

Countries

Belgium