Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects. Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation. Furthermore, during the course of the study, safety and tolerability will be characterized.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jan 2012
Shorter than P25 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
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 18, 2012
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedApril 20, 2012
April 1, 2012
2 months
April 18, 2012
April 19, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects
Secondary Outcomes (7)
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
Number of adverse events
Changes in vital signs as measured by heart rate, blood pressure and body temperature
Changes on 12-lead ECG measures
- +2 more secondary outcomes
Study Arms (4)
Period 1: formulation 1 oral solution
EXPERIMENTALPeriod 2: formulation 2 capsule
EXPERIMENTALPeriod 3: Selected formulation + food
EXPERIMENTALPeriod 4: Selected formulation at higher dose
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Healthy male, age 18-50 years
- BMI between 18-30 kg/m2
You may not qualify if:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galapagos NVlead
Study Sites (1)
SGS Stuivenberg
Antwerp, Antwerp, Belgium
Study Officials
- STUDY DIRECTOR
Frédéric Vanhoutte, MD
Galapagos NV
- PRINCIPAL INVESTIGATOR
Eva Vets, MD
SGS Stuivenberg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2012
First Posted
April 19, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
April 20, 2012
Record last verified: 2012-04