Food Effect on Pharmacokinetic Parameters of ABX464

Healthy Volunteers Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02731885
• Study type: Interventional
• Source: Abivax S.A.
• Status: Completed
• Phase: Phase 1
• Start date: September 2014
• Completion date: June 2015