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A Study With GLPG1972 in Osteoarthritis Subjects

NCT03311009 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-11-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Ann Fieuw, MD, MSc · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-10-25
Completion
2017-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311009 on ClinicalTrials.gov