First-in-Human Single Ascending Dose of GLPG0492

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: placebo; Drug: GLPG0492

Study type: Interventional

Funder types: Industry

Identifiers

NCT01130818

GLPG0492-CL-101

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

single ascending doses

Treatment:

Drug: GLPG0492

Drug: GLPG0492

Drug: GLPG0492

2

Placebo Comparator group

Description:

single dose placebo

Treatment:

Drug: placebo

3

Experimental group

Description:

single dose, oral solution, 50 mg

Treatment:

Drug: GLPG0492

Drug: GLPG0492

Drug: GLPG0492

4

Experimental group

Description:

single dose, capsules (fasting)

Treatment:

Drug: GLPG0492

Drug: GLPG0492

Drug: GLPG0492

5

Experimental group

Description:

single dose, capsules (fed)

Treatment:

Drug: GLPG0492

Drug: GLPG0492

Drug: GLPG0492