Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: GLPG0634 100mg capsule once a day for 10 days

Arms, Groups and Cohorts

  • Experimental: 40-50 years old
    • GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
  • Experimental: 65-74 years old
    • GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old
  • Experimental: 75 years and older
    • GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Galapagos NV
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Frédéric Vanhoutte, MD, Study Director, Galapagos NV
    • Magdalena Petkova, MD, Principal Investigator, SGS LSS Clinical Pharmacology Unit Antwerp

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