Conditions: Healthy
Keywords: Fasting Fed condition Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: yes

Brief summary:
This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

Detailed description:
The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Arms:
arm 1: A single dose of RP6530 following fast condition arm 2: A single dose of RP6530 following fed condition

Interventions: intervention 1: RP6530
Intervention descriptions: intervention 1: Single oral dose

Protocol document: