Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects

Phase 1CompletedNCT01208753

Lakefront Biotherapeutics NV24 enrolled

Overview

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG0555DRUG

two different aqueous formulations

GLPG0555 aqueousDRUG

multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined

placeboDRUG

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

SGS Stuivenberg

Antwerp, Belgium

Outcomes

Primary Outcomes

Safety and tolerability of multiple dosing

Time frame: Daily during treatment, up to 10 days postdose

Secondary Outcomes

Pharmacokinetics of repeated doses

Time frame: 24 hours postdose

Pharmacodynamics (PD) of GLPG0555 after repeated oral administration

Time frame: up to 10 days postdose

The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days

Time frame: up to 24 hours postdose

Data from ClinicalTrials.gov

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