First-in-Human Single Ascending and Multiple Dose of GLPG0555

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 and Multiple Oral Doses of GLPG0555 in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023321
• Other study ID #: GLPG0555-CL-101
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2009
• Last updated: August 11, 2010
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: August 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) and multiple (MD) oral dose of GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• 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:
• GLPG0555
single ascending doses, oral solution
• placebo
single dose, oral solution
• GLPG0555
multiple dose, oral solution, 7 or 14 days
• placebo
multiple dose, oral solution, 7 or 14 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, including effect of food.		up to 10 days postdose	No
Secondary	To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration		up to 72 hours postdose	No