First-in-Human Single Ascending Dose of GLPG0492

Lakefront Biotherapeutics NV28 enrolled

Overview

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

GLPG0492DRUG

single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)

placeboDRUG

single dose, oral solution

GLPG0492DRUG

single dose, solid formulation, 50 mg (2\*25 mg/capsule), fasting

Eligibility

Sex: MALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects) * BMI between 18-30 kg/m², inclusive * non-smoker Exclusion Criteria: * elevated PSA * drug or alcohol abuse

Locations (1)

SGS Stuivenberg

Antwerp, Belgium

Outcomes

Primary Outcomes

Safety and tolerability of single ascending doses in healthy young and elderly subjects.

Time frame: up to 10 days postdose

Secondary Outcomes

Pharmacokinetics of single oral doses (solution) in young and elderly subjects.

Time frame: up to 10 days postdose

Determine oral bioavailability of GLPG0492 given to elderly subjects as oral solution or solid dosage form with or without food.

Time frame: up to 10 days postdose

Determine the maximum tolerated dose in young subjects.

Time frame: Up to 10 days postdose

Data from ClinicalTrials.gov

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