Oral Bioavailability of GLPG0555 in Different Solid Formulations

Galapagos NV12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

GLPG0555 solid dispersionDRUG

solid dispersion capsules, 50 mg, single dose

GLPG0555 nanosuspensionDRUG

Nanosuspension, 50 mg, single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male * BMI between 18-30 kg/m², inclusive. Exclusion Criteria: * significantly abnormal platelet function or coagulopathy * smoking * drug or alcohol abuse

Locations (1)

SGS Stuivenberg

Antwerp, Belgium

Outcomes

Primary Outcomes

Bioavailability of solid formulation

Time frame: 72 hrs

Secondary Outcomes

Safety and tolerability of single doses of GLPG0555

Time frame: up to 10 days postdose

Data from ClinicalTrials.gov

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