NCT04106297

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970

A First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GLPG3970 Single and Multiple Ascending Doses in Adult Healthy Male Subjects, and in Psoriasis Subjects When Administered Daily for 6 Weeks

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.

Conditions

• Healthy
• Psoriasis

Interventions

Type	Name	Description
DRUG	GLPG3970 oral solution	GLPG3970 for oral administration
DRUG	Placebo oral solution	Placebo for oral administration
DRUG	GLPG3970 capsule	GLPG3970 for oral administration

Timeline

• Start date: 2019-09-10
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2019-09-27
• Last updated: 2024-09-19

Locations

3 sites across 3 countries: Belgium, Moldova, Ukraine