ClinicalTrials.gg
Sign In
CompletedNCT01322451Updated Mar 24, 2011

Oral Bioavailability of Two Solid Formulations of GLPG0259.

A Phase 1 interventional study of GLPG0259 fumarate and GLPG0259 free base in Healthy, sponsored by Lakefront Biotherapeutics NV. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-03-24.

Sponsored by Lakefront Biotherapeutics NV · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Safety
  • Tolerability
  • Pharmacokinetics
03

In context

Lead sponsor

Lakefront Biotherapeutics NV is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Browse Lakefront Biotherapeutics NV studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • significantly abnormal platelet function or coagulopathy
  • smoking
  • drug or alcohol abuse
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Single oral dose, single capsule

    Drug: GLPG0259 free base

  • Experimental
    Single oral dose, two capsules

    Drug: GLPG0259 fumarate

Interventions

06

What researchers measure

Primary outcomes

  1. Bioavailability of two solid dosage formulations of GLPG0259

    Time frame: up to 96 hours postdose

Secondary outcomes

  1. Safety and tolerability of GLPG0259

    Time frame: up to 96 hours postdose

07

Study locations

1 site
  • SGS Stuivenberg
    Antwerp, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2010, a primary completion of Dec 2010 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2011
First posted
Mar 24, 2011
Start
Nov 2010
Primary completionActual
Dec 2010
CompletionActual
Jan 2011
Last update
Mar 24, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01322451
Lead sponsor
Lakefront Biotherapeutics NV
First posted
Mar 24, 2011
Start date
Nov 2010
Primary completion
Dec 2010
Completion
Jan 2011
Last update
Mar 24, 2011

Study contacts

Johan Beetens, PharmD, PhD
study director · Lakefront Biotherapeutics NV
Lien Gheyle, MD
principal investigator · SGS Stuivenberg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: GLPG-0259

Other studies from this sponsor

Lakefront Biotherapeutics NV →

Start the discussion