NCT02690727

To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RP6530	Single oral dose

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2016-02-24
• Last updated: 2017-11-28
• Results posted: 2017-06-16

Locations

1 site across 1 country: Canada