First-in-Human Single Ascending Dose of GLPG0492

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GLPG0492; Drug: placebo

• Registration Number: NCT01130818
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GLPG0492	single ascending doses
2	placebo	single dose placebo
3	GLPG0492	single dose, oral solution, 50 mg
5	GLPG0492	single dose, capsules (fed)
4	GLPG0492	single dose, capsules (fasting)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single ascending doses in healthy young and elderly subjects.	up to 10 days postdose

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of single oral doses (solution) in young and elderly subjects.	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.	up to 10 days postdose
Determine the maximum tolerated dose in young subjects.	Up to 10 days postdose

Trial Locations

Locations (1)

SGS Stuivenberg; 🇧🇪 Antwerp, Belgium