First-in-Human Single Ascending Dose of GLPG0492

Healthy Clinical Trial

Official title:

Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GLPG0492 in Healthy Subjects and Open Relative Bioavailability Study of Oral Solution Versus Solid Formulation, Fasted and Fed, in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130818
• Other study ID #: GLPG0492-CL-101
• Status: Completed
• Phase: Phase 1
• Start date: May 2010
• Est. completion date: September 2010

Study information

• Verified date: February 2024
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• GLPG0492
single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
• placebo
single dose, oral solution
• GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
• GLPG0492
single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast

Locations

Country	Name	City	State
Belgium	SGS Stuivenberg	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single ascending doses in healthy young and elderly subjects.		up to 10 days postdose
Secondary	Pharmacokinetics of single oral doses (solution) in young and elderly subjects.		up to 10 days postdose
Secondary	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
Secondary	Determine the maximum tolerated dose in young subjects.		Up to 10 days postdose