NCT01023321

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 12, 2010

Status Verified

August 1, 2010

Enrollment Period

4 months

First QC Date

December 1, 2009

Last Update Submit

August 11, 2010

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of single and multiple dosing

    up to 10 days postdose

Secondary Outcomes (2)

  • Pharmacokinetics of single and repeated doses, including effect of food.

    up to 10 days postdose

  • To characterize the in/ex vivo pharmacodynamics (PD) of GLPG0555 after single and repeated oral administration

    up to 72 hours postdose

Study Arms (4)

1

EXPERIMENTAL

single ascending doses

Drug: GLPG0555

2

PLACEBO COMPARATOR

single dose placebo

Drug: placebo

3

EXPERIMENTAL

multiple dose, 7 or 14 days, oral solution

Drug: GLPG0555

4

PLACEBO COMPARATOR

multiple dose, 7 or 14 days, oral solution

Drug: placebo

Interventions

GLPG0555DRUG

single ascending doses, oral solution

1
placeboDRUG

single dose, oral solution

2

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male, age 18-50 years
  • BMI between 18-30 kg/m², inclusive.

You may not qualify if:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SGS Stuivenberg

Antwerp, Belgium

Location

Study Officials

  • Gerben van 't Klooster, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Wouter Haazen, MD

    SGS Stuivenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

August 12, 2010

Record last verified: 2010-08

Locations

BE(1)