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GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study

NCT01336244 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

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 multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.

Conditions

  • Healthy

Interventions

DRUG

GLPG0778

capsules containing 50 or 100 mg of GLPG0778

DRUG

placebo

multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule

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
2011-04-30
Primary Completion
2011-08-31
Completion
2011-09-30

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 NCT01336244 on ClinicalTrials.gov