First-in-Human Single Ascending Dose of GLPG0492

NCT ID: NCT01130818

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-09-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

1

single ascending doses

Group Type: EXPERIMENTAL

GLPG0492

Intervention Type: DRUG

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

2

single dose placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

single dose, oral solution

3

single dose, oral solution, 50 mg

Group Type: EXPERIMENTAL

GLPG0492

Intervention Type: DRUG

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

4

single dose, capsules (fasting)

Group Type: EXPERIMENTAL

GLPG0492

Intervention Type: DRUG

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

5

single dose, capsules (fed)

Group Type: EXPERIMENTAL

GLPG0492

Intervention Type: DRUG

single dose, solid formulation, 50 mg (2\*25 mg/capsule), after high fat breakfast

Interventions

GLPG0492

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

Intervention Type: DRUG

placebo

single dose, oral solution

Intervention Type: DRUG

GLPG0492

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

Intervention Type: DRUG

GLPG0492

single dose, solid formulation, 50 mg (2\*25 mg/capsule), after high fat breakfast

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Galapagos NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Florence Namour, PhD

Role: STUDY_DIRECTOR

Galapagos NV

Sofie Mesens, MD

Role: PRINCIPAL_INVESTIGATOR

SGS Stuivenberg

Locations

SGS Stuivenberg

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

GLPG0492-CL-101

Identifier Type: -

Identifier Source: org_study_id