NCT01024517

Brief Summary

The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 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

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

April 27, 2010

Status Verified

April 1, 2010

Enrollment Period

1 month

First QC Date

December 1, 2009

Last Update Submit

April 26, 2010

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of a solid dosage formulation of GLPG0259 (with/without food) compared to an oral solution of GLPG0259.

    up to 96 hours postdose

Secondary Outcomes (1)

  • Safety and tolerability of GLPG0259

    up to 96 hours postdose

Study Arms (3)

Single oral dose, solution

EXPERIMENTAL
Drug: GLPG0259 solution

Single oral dose, solid, fasted

EXPERIMENTAL
Drug: GLPG0259

Single oral dose, solid, fed.

EXPERIMENTAL
Drug: GLPG0259

Interventions

GLPG0259 solutionDRUG

single oral dose, GLPG0259, 50 mg oral solution

Single oral dose, solution
GLPG0259DRUG

single oral dose, GLPG0259, 50 mg solid formulation

Single oral dose, solid, fastedSingle oral dose, solid, fed.

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

  • Wouter Haazen, MD

    SGS Stuivenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

April 27, 2010

Record last verified: 2010-04

Locations

BE(1)