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First-in-Human Single Ascending and Multiple Dose of GLPG0555

NCT01023321 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-08-12

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 dose of GLPG0555 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG555 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

  • Healthy

Interventions

DRUG

GLPG0555

single ascending doses, oral solution

DRUG

placebo

single dose, oral solution

DRUG

GLPG0555

multiple dose, oral solution, 7 or 14 days

DRUG

placebo

multiple dose, oral solution, 7 or 14 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Gerben van 't Klooster, PhD · Galapagos NV

  • Wouter Haazen, MD · SGS Stuivenberg

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-04-30
Completion
2010-05-31

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 NCT01023321 on ClinicalTrials.gov