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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: placebo; Drug: GLPG0555; Drug: GLPG0555 aqueous

• Registration Number: NCT01208753
• Lead Sponsor: Galapagos NV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-23
• Study First Posted: 2010-09-24
• Primary Completion: 2010-11
• Study Completion: 2011-02
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-22
• Last Update Posted: 2011-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	placebo	once or twice daily for 13 days, matching the scheme of the multiple ascending dose.
Aqueous formulations for formulation selection	GLPG0555	50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation
GLPG0555 ascending doses	GLPG0555 aqueous	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)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of multiple dosing	Daily during treatment, up to 10 days postdose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of repeated doses	24 hours postdose
Pharmacodynamics (PD) of GLPG0555 after repeated oral administration	up to 10 days postdose
The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days	up to 24 hours postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium