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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

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

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