NCT02731885

Food Effect on Pharmacokinetic Parameters of ABX464

An Open, Randomized Study, to Investigate the Potential Food Effect on Pharmacokinetic Parameters of ABX464 Administered Orally to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to determine the impact of the food on the absorption of the ABX464.

Detailed description

This is a phase I, single-center, open-label, two-treatment, food-effect, randomized study in 40 healthy Caucasian male subjects in order to determine the impact of the food on the absorption of the ABX464. The two different treatments are the followings: * Treatment A = 50mg of ABX464 (two 25mg capsules) /Fasted * Treatment B = 50mg of ABX464 (two 25mg capsules) / Fed This study consists of two groups: * Group 1 - single dose assessments, two-period, two-treatment, cross-over: 20 subjects will receive a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days. * Group 2 - multiple dose assessments: 20 subjects will receive 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ABX464 Single dose	Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
DRUG	ABX464 Repeated dose	Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2016-04-08
• Last updated: 2016-04-08

Locations

1 site across 1 country: Mauritius