Oral Bioavailability of Two Solid Formulations of GLPG0634

Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01915667

Enrollment

Registered

2013-08-05

Start date

2013-07-31

Completion date

2013-09-30

Last updated

2013-09-17

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 administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects. Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Interventions

DRUG200 mg GLPG0634 as capsules, fasted

single oral dose of 200 mg GLPG0634 given as capsules in fasted condition

DRUG200 mg GLPG0634 as tablets, fasted

single oral dose of 200 mg GLPG0634 given as tablets in fasted condition

DRUG200 mg GLPG0634 as tablets, fed

single oral dose of 200 mg GLPG0634 given as tablets in fed condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male, age 40-60 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 GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets	From predose (before first study drug administration) up to 144 hours post last study drug administration	To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.

Secondary

Measure	Time frame	Description
The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets	Between screening and 7-10 days after the last dose	To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG)

Countries

Belgium

Outcome results

None listed

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