Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food
A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food
2 other identifiers
interventional
12
1 country
1
Brief Summary
The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects. Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.
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 May 2014
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
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 18, 2014
CompletedFirst Posted
Study publicly available on registry
May 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJuly 22, 2014
July 1, 2014
2 months
May 18, 2014
July 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The amount of GLPG1205 in plasma
To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.
From predose up to 504 hours (Day 22) after study drug administration
Secondary Outcomes (5)
The number of subjects with adverse events
From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal laboratory parameters
From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal vital signs
From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal electrocardiogram (ECG)
From screening up to 28 (+/-2) days after last study drug administration
The number of subjects with abnormal physical examination
From screening up to 28 (+/-2) days after last study drug administration
Study Arms (2)
100 mg GLPG1205 fasted
EXPERIMENTALSingle dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast
100 mg GLPG1205 fed
EXPERIMENTALSingle dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast
Interventions
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
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 LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, Belgium
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Frédéric Vanhoutte, MD
Galapagos NV
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2014
First Posted
May 21, 2014
Study Start
May 1, 2014
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
July 22, 2014
Record last verified: 2014-07