First-in-Human Single Ascending and Multiple Dose of GLPG0259

Healthy Clinical Trial

Official title:

Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00905138
• Other study ID #: GLPG0259-CL-101
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2009
• Last updated: February 17, 2012
• Start date: March 2009
• Est. completion date: June 2009

Study information

• Verified date: February 2012
• 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) and multiple (MD) oral dose of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2009
• Est. primary completion date: June 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:
• GLPG0259
single ascending doses, oral solution
• placebo
single dose, oral solution
• GLPG0259
multiple dose, oral solution, 5 days
• placebo
oral solution, 5 days

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 and multiple dosing		up to 10 days postdose	Yes
Secondary	Pharmacokinetics of single and repeated doses		up to 10 days postdose	No
Secondary	Exploratory evaluation of TNF-alpha and IL6 in whole blood		up to 12 hours postdose	No