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First-in-Human Single Ascending and Multiple Dose of GLPG0778

NCT01278108 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-10-18

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 GLPG0778 compared to placebo (with and without food).

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Conditions

  • Healthy

Interventions

DRUG

GLPG0778

single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)

DRUG

placebo

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

DRUG

GLPG0778

multiple dose, capsule, 7 days

DRUG

placebo

multiple dose, capsule, 7 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Gerben van 't Klooster, PhD · Galapagos NV

  • Lien Gheyle, 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
2010-12-31
Primary Completion
2011-02-28
Completion
2011-05-31

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 NCT01278108 on ClinicalTrials.gov