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Completed

NCT Number: NCT01024517

GLPG0259 Solid Formulation Bioavailability and Food Effect

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

GLPG0259 solution

Drug

single oral dose, GLPG0259, 50 mg oral solution

GLPG0259

Drug

single oral dose, GLPG0259, 50 mg solid formulation

Primary outcomes

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

    Time frame: up to 96 hours postdose

Secondary outcomes

  1. Safety and tolerability of GLPG0259

    Time frame: up to 96 hours postdose

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

An Open Label Study to Compare the Oral Bioavailability of a Solid Dose Formulation of GLPG0259 Relative to an Oral Solution After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Solid Dose Formulation.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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