NCT03311009

A Study With GLPG1972 in Osteoarthritis Subjects

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ascending Doses of GLPG1972 for 4 Weeks in Subjects With Osteoarthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, stratified, ascending dose, single center study, in three semi-sequential cohorts of 10 male and female subjects of nonchildbearing potential with Osteoarthritis (OA), administered GLPG1972 or placebo. Per cohort, 10 subjects will be randomized in a 4:1 allocation ratio to active treatment with GLPG1972 or matching placebo. In each cohort, OA subjects will be stratified for age (50- 64 years and 65-75 years) with a minimum of 2 of each sex per age group.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	GLPG1972 cohort 1	GLPG1972 dose 1 provided as oral tablets q.d.
DRUG	GLPG1972 cohort 2	GLPG1972 dose 2 provided as oral tablets q.d.
DRUG	GLPG1972 cohort 3	GLPG1972 dose 3 provided as oral tablets q.d.
DRUG	Placebo	Matching placebo provided as oral tablets q.d.

Timeline

• Start date: 2017-05-15
• Primary completion: 2017-10-25
• Completion: 2017-10-25
• First posted: 2017-10-16
• Last updated: 2017-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study