Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

NCT ID: NCT01208753

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-02-28

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

Aqueous formulations for formulation selection

50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation

Group Type: EXPERIMENTAL

GLPG0555

Intervention Type: DRUG

two different aqueous formulations

GLPG0555 ascending doses

multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily)

Group Type: EXPERIMENTAL

GLPG0555 aqueous

Intervention Type: DRUG

multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined

3

once or twice daily for 13 days, matching the scheme of the multiple ascending dose.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Interventions

GLPG0555

two different aqueous formulations

Intervention Type: DRUG

GLPG0555 aqueous

multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined

Intervention Type: DRUG

placebo

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Galapagos NV

Principal Investigators

Gerben van 't Klooster, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Wouter Haazen, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

SGS Stuivenberg

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

2010-018570-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GLPG0555-CL-102

Identifier Type: -

Identifier Source: org_study_id