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Completed

NCT Number: NCT00989703

GLPG0259 Multiple Ascending Dose and Methotrexate Drug-drug Interaction (DDI) in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple increasing oral doses of GLPG0259 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after multiple increasing oral doses, and potential drug-drug interaction with single dose methotrexate will be assessed.

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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

Placebo

Drug

oral solution, daily for 14 days

GLPG0259

Drug

oral solution

methotrexate

Drug

7.5 mg (3 tablets, 2.5 mg/tablet) on study days D-1 and D14

Other names: Ledertrexate®

Primary outcomes

  1. Safety and tolerability of oral multiple ascending doses

    Time frame: up to 10 days postdose

Secondary outcomes

  1. Pharmacokinetics of multiple oral doses

    Time frame: up to 10 days postdose

  2. To explore the pharmacokinetic interaction between GLPG0259 and methotrexate (MTX).

    Time frame: up to 10 days postdose

  3. To explore biomarkers of GLPG0259 activity after multiple oral administrations.

    Time frame: up to 24 hours postdose

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Double Blind, Placebo Controlled, Dose Ranging and Methotrexate Interaction Study for the Assessment of Safety, Tolerability and Pharmacokinetics (PK) of Multiple Oral Doses of GLPG0259 in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Oct 5, 2009
Registry last updated
Feb 20, 2012

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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