Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Sep 2010
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 23, 2010
CompletedFirst Posted
Study publicly available on registry
September 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 23, 2011
March 1, 2011
2 months
September 23, 2010
March 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of multiple dosing
Daily during treatment, up to 10 days postdose
Secondary Outcomes (3)
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
Study Arms (3)
Aqueous formulations for formulation selection
EXPERIMENTAL50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation
GLPG0555 ascending doses
EXPERIMENTALmultiple 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)
3
PLACEBO COMPARATORonce or twice daily for 13 days, matching the scheme of the multiple ascending dose.
Interventions
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
Eligibility Criteria
You may qualify if:
- healthy male, age 18-50 years
- BMI between 18-30 kg/m², inclusive.
You may not qualify if:
- significantly abnormal platelet function or coagulopathy
- smoking
- drug or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galapagos NVlead
Study Sites (1)
SGS Stuivenberg
Antwerp, Belgium
Study Officials
- STUDY DIRECTOR
Gerben van 't Klooster, PhD
Galapagos NV
- PRINCIPAL INVESTIGATOR
Wouter Haazen, MD
SGS Stuivenberg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 23, 2010
First Posted
September 24, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2010
Study Completion
February 1, 2011
Last Updated
March 23, 2011
Record last verified: 2011-03