CompletedNCT00928343Updated Jan 15, 2010

First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187

A Phase 1 interventional study of GLPG0187 and Placebo in Healthy, sponsored by Galapagos NV. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-15.

Sponsored by Galapagos NV · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: Male

Study summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions studied

Healthy

Keywords

Safety
Tolerability
Pharmacokinetics

In context

Lead sponsor

Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

Inclusion criteria

healthy male, age 18-50 years
BMI between 18-30 kg/m², inclusive

Exclusion criteria

Exclusion Criteria:

significantly abnormal platelet function or coagulopathy
smoking
drug or alcohol abuse

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 18 participants (actual)

Study arms

Experimental
GLPG0187
Single dose
Drug: GLPG0187
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugGLPG0187
Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
DrugPlacebo
Matching subcutaneous or oral placebo

What researchers measure

Primary outcomes

Safety and tolerability of single subcutaneous and oral dosing
Time frame: up to day 10 postdose

Secondary outcomes

Pharmacokinetics of single subcutaneous and oral doses
Time frame: up to 10 days postdose
Exploratory evaluation of S-CTX
Time frame: up to 24 hrs postdose

Study locations

1 site

SGS Stuivenberg
Antwerp, Belgium

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00928343
Lead sponsor: Galapagos NV
First posted: Jun 25, 2009
Start date: Jun 2009
Primary completion: Nov 2009
Completion: Dec 2009
Last update: Jan 15, 2010

Study contacts

Giocondo Lorenzon, PhD

study director · Galapagos NV

Eva Vets, MD

principal investigator · SGS Stuivenberg

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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