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Completed

NCT Number: NCT01665924

Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

The purpose of the study is to evaluate the amount of compound present in the blood (pharmacokinetics) after single and of multiple doses of GLPG0634 in elderly healthy subjects.

During the course of the study, the effect of aging on the pharmacokinetics as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be assessed and the safety of multiple oral doses of GLPG0634 in elderly healthy subjects will be characterized.

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Key information

Conditions

Healthy

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerp

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 or female, age 40 years and older
  • 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 100mg capsule once a day for 10 days

Drug

Primary outcomes

  1. The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634

    Time frame: From predose (before first study drug administration) up to 72 hours post last study drug administration

    To characterize the amount of GLPG0634 in plasma over time - pharmacokinetics (PK) - after single and multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging

Secondary outcomes

  1. The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634

    Time frame: From predose (before first study drug administration) up to 24 hours post last study drug administration

    To characterize the effects of GLPG0634 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - after multiple oral doses in different age groups, including elderly healthy subjects, thereby assessing the effect of aging

  2. Number of adverse events

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of the number of adverse events reported

  3. Changes in vital signs as measured by heart rate, blood pressure and body temperature

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported

  4. Changes in 12-lead ECG measures

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in 12-ECG measures reported

  5. Changes in physical exam measures

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in physical examination reported

  6. Changes in blood safety lab parameters

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in blood safety lab parameters assessed

  7. Changes in urine safety lab parameters

    Time frame: From screening up to 10 days after the last study drug administration

    To evaluate the safety of multiple oral doses of GLPG0634 in healthy subjects of different age groups, including elderly, in terms of changes in urine safety lab parameters assessed

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 16, 2012
Registry last updated
Mar 28, 2013

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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