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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02143856

Enrollment

Registered

2014-05-21

Start date

2014-05-31

Completion date

2014-07-31

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUG100 mg GLPG1205

A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male, age 18-50 years * BMI between 18-30 kg/m2

Exclusion criteria

* Any condition that might interfere with the procedures or tests in this study * Drug or alcohol abuse * Smoking

Design outcomes

Primary

Measure	Time frame	Description
The amount of GLPG1205 in plasma	From predose up to 504 hours (Day 22) after study drug administration	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.

Secondary

Measure	Time frame	Description
The number of subjects with adverse events	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)
The number of subjects with abnormal laboratory parameters	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters
The number of subjects with abnormal vital signs	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs
The number of subjects with abnormal electrocardiogram (ECG)	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)
The number of subjects with abnormal physical examination	From screening up to 28 (+/-2) days after last study drug administration	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026