NCT00928343

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

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

• Healthy

Interventions

Type	Name	Description
DRUG	GLPG0187	Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
DRUG	Placebo	Matching subcutaneous or oral placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-06-25
• Last updated: 2010-01-15

Locations

1 site across 1 country: Belgium