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OpenTrials
Completed

NCT Number: NCT01322451

Oral Bioavailability of Two Solid Formulations of GLPG0259.

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

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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 fumarate

Drug

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

GLPG0259 free base

Drug

single oral dose, GLPG0259, 50 mg solid formulation

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

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

A Randomized, Open Label, 2-way Crossover Study to Compare the Oral Bioavailability of 2 Solid Dose Formulations of GLPG0259 After Single-dose Intake in Healthy Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 24, 2011
Registry last updated
Mar 24, 2011

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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