First-in-Human Single Ascending and Multiple Dose of GLPG0555

Lakefront Biotherapeutics NV35 enrolled

Overview

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0555 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG0555DRUG

single ascending doses, oral solution

placeboDRUG

single dose, oral solution

GLPG0555DRUG

multiple dose, oral solution, 7 or 14 days

placebo

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 single and multiple dosing

Time frame: up to 10 days postdose

Secondary Outcomes

Pharmacokinetics of single and repeated doses, including effect of food.

Time frame: up to 10 days postdose

To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration

Time frame: up to 72 hours postdose

Data from ClinicalTrials.gov

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