NCT01322451

Brief Summary

The purpose of the study is to evaluate the relative bioavailability of two solid oral formulations of GLPG0259 administered after a meal.

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 2010

Shorter than P25 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

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

1 month

First QC Date

March 22, 2011

Last Update Submit

March 23, 2011

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Bioavailability of two solid dosage formulations of GLPG0259

    up to 96 hours postdose

Secondary Outcomes (1)

  • Safety and tolerability of GLPG0259

    up to 96 hours postdose

Study Arms (2)

Single oral dose, single capsule

EXPERIMENTAL
Drug: GLPG0259 free base

Single oral dose, two capsules

EXPERIMENTAL
Drug: GLPG0259 fumarate

Interventions

GLPG0259 fumarateDRUG

single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate

Single oral dose, two capsules
GLPG0259 free baseDRUG

single oral dose, GLPG0259, 50 mg solid formulation

Single oral dose, single capsule

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

  • Lien Gheyle, 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

March 22, 2011

First Posted

March 24, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

BE(1)