NCT00905138

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 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
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2009

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

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

February 20, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

May 18, 2009

Last Update Submit

February 17, 2012

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

    up to 10 days postdose

  • Exploratory evaluation of TNF-alpha and IL6 in whole blood

    up to 12 hours postdose

Study Arms (4)

1

EXPERIMENTAL

single ascending doses

Drug: GLPG0259

2

PLACEBO COMPARATOR

single dose placebo

Drug: placebo

3

EXPERIMENTAL

multiple dose, 5 days, oral solution

Drug: GLPG0259

4

PLACEBO COMPARATOR

multiple dose, 5 days, oral solution

Drug: placebo

Interventions

GLPG0259DRUG

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

  • Johan Beetens, PharmD, PhD

    Galapagos NV

    STUDY DIRECTOR

  • Eva Vets, 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

May 18, 2009

First Posted

May 20, 2009

Study Start

March 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

February 20, 2012

Record last verified: 2012-02

Locations

BE(1)