Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets
Open-Label, Randomized, 3-Way Crossover Design to Assess the Relative Bioavailability of JNJ-42756493 Tablets
The purpose of this study is to assess the relative bioavailability of 2 prototype G-025 tablets compared with the current G-018 tablet.
This is an open-label (all people know the identity of the intervention), multi-period, randomized (study drug assigned by chance), single-dose, 3-way crossover study. The study consists of 21-day screening period, 3 open-label treatment periods with a minimum 21 (+-2)-day washout between doses, and end-of-study assessments 10 (+-2) days after the last dose. The duration of study is approximately 3 months. Participants will be randomized to 1 of 6 treatment sequences as follows: Treatment sequence 1=ABC, 2=BCA, 3=CAB, 4=ACB, 5=BAC AND 6=CBA. Treatment A=JNJ-42756493 current clinical formulation, 10 milligrams (mg) (2 tablets of 5 mg each). Treatment B= JNJ-42756493 Prototype Formulation I (G-025), 10 mg (2 tablets of 5 mg each) and Treatment C=JNJ-42756493 Prototype Formulation II (G-025), 10 mg (2 tablets of 5 mg each). Blood samples will be collected to determine pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
Inclusion Criteria:
Exclusion Criteria: