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

Healthy Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928343
• Other study ID #: GLPG0187-CL-101
• Status: Completed
• Phase: Phase 1
• First received: June 23, 2009
• Last updated: January 14, 2010
• Start date: June 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• healthy male, age 18-50 years

• BMI between 18-30 kg/m², inclusive

Exclusion Criteria:

• significantly abnormal platelet function or coagulopathy

• smoking

• drug or alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0187
Single ascending subcutaneous doses (subcutaneous solution), and single oral dose (oral solution)
• Placebo
Matching subcutaneous or oral placebo

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single subcutaneous and oral dosing		up to day 10 postdose	No
Secondary	Pharmacokinetics of single subcutaneous and oral doses		up to 10 days postdose	No
Secondary	Exploratory evaluation of S-CTX		up to 24 hrs postdose	No