drugset / Trial / NCT02662452

First-in-Human Single and Multiple Dose of GLPG2222

NCT02662452 ↗

Phase 1 Completed 40 enrolled Lakefront Biotherapeutics NV
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2). Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized. The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Timeline

Start
2016-01
Primary completion
2016-04
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Galicaftor Small molecule — Oral

Indications

No indication recorded.