drugset / Trial / NCT04097938

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

NCT04097938 ↗

Phase 1 Completed 52 enrolled Lakefront Biotherapeutics NV
RandomizedSequentialQuadruple-blindBasic science

Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Timeline

Start
2019-09-18
Primary completion
2020-03-04
Completion
2020-07-06

Drugs

EvaluationDrugModalityDoseRoute
Subject GLPG3667 Small molecule — Oral

Indications

No indication recorded.