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First-in-Human Single Ascending and Multiple Dose of GLPG0634

NCT01179581 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-03-24

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0634 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

  • Healthy

Interventions

DRUG

GLPG0634

single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)

DRUG

placebo

single dose, oral solution or capsule (matching corresponding study medication)

DRUG

GLPG0634

multiple dose, capsule, 10 days

DRUG

placebo

multiple dose, capsule, 10 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Gerben van 't Klooster, PhD · Galapagos NV

  • Eva Vets, MD · SGS Stuivenberg

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-03-31
Completion
2011-03-31

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 NCT01179581 on ClinicalTrials.gov