Oral Bioavailability of Two Solid Formulations of GLPG0259.

A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01322451

Enrollment

Registered

2011-03-24

Start date

2010-11-30

Completion date

2011-01-31

Last updated

2011-03-24

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

Conditions

Healthy

Keywords

Safety, Tolerability, Pharmacokinetics

Brief summary

The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

Interventions

DRUGGLPG0259 fumarate

single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate

DRUGGLPG0259 free base

single oral dose, GLPG0259, 50 mg solid formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

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, inclusive.

Exclusion criteria

* significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame
Bioavailability of two solid dosage formulations of GLPG0259	up to 96 hours postdose

Secondary

Measure	Time frame
Safety and tolerability of GLPG0259	up to 96 hours postdose

Countries

Belgium

Outcome results

None listed

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