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Completed

NCT Number: NCT01419990

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

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Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Stuivenberg

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male, age 40-60 years
  • BMI between 18-30 kg/m2

Exclusion criteria

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Treatment and study plan

GLPG0634

Drug

GLPG0634 300 mg oral capsules, qd, 10 days

Placebo

Drug

Placebo oral capsules, qd, 10 days

Primary outcomes

  1. Safety and tolerability

    Time frame: From screening up to 10 days after the last dose

    To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments

Secondary outcomes

  1. Pharmacokinetics (PK) and pharmacodynamics (PD)

    Time frame: From first dose up to 10 days after the last dose

    To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 19, 2011
Registry last updated
Aug 15, 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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