drugset / Trial / NCT03010059

A Study to Assess the Relative Bioavailability of JNJ64041575 Administered as 2 Different New Concept Formulations (Oral Suspension and Tablet) Compared to Their Respective Current Formulations, and to Assess the Effect of Food on the Pharmacokinetics of the 2 New Concept Formulations

NCT03010059

Phase 1 Completed 48 enrolled Janssen Research & Development, LLC
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to assess the rate and extent of absorption of JNJ-64041575 by measuring ALS-008112 plasma concentrations following administration of a single oral dose of JNJ-64041575 given as 2 new concept formulations (oral suspension and tablet) compared to their respective current formulations under fasted conditions and to assess the effect of food on the pharmacokinetics of the 2 new concept formulations under fed condition in healthy adult participants.

Timeline

Start
2017-02-06
Primary completion
2017-05-29
Completion
2017-05-29

Drugs

EvaluationDrugModalityDoseRoute
Subject JNJ-64041575 Unknown 240 mg Oral
Subject JNJ-64041575 Unknown 250 mg Oral

Indications

No indication recorded.