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First-in-Human Single Ascending Dose of GLPG0492

NCT01130818 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-03-01

No results posted yet for this study

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

Interventions

DRUG

GLPG0492

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

DRUG

placebo

single dose, oral solution

DRUG

GLPG0492

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

DRUG

GLPG0492

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

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Florence Namour, PhD · Galapagos NV

  • Sofie Mesens, MD · SGS Stuivenberg

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01130818 on ClinicalTrials.gov