Oral Bioavailability of GLPG0555 in Different Solid Formulations

A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01278095

Enrollment

Registered

2011-01-17

Start date

2011-01-31

Completion date

2011-03-31

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 compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Interventions

DRUGGLPG0555 solid dispersion

solid dispersion capsules, 50 mg, single dose

DRUGGLPG0555 nanosuspension

Nanosuspension, 50 mg, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy male * 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 solid formulation	72 hrs

Secondary

Measure	Time frame
Safety and tolerability of single doses of GLPG0555	up to 10 days postdose

Countries

Belgium

Outcome results

None listed

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