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Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665924
First Posted: August 16, 2012
Last Update Posted: March 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galapagos NV
  Purpose

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.


Condition Intervention Phase
Healthy Drug: GLPG0634 100mg capsule once a day for 10 days Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Further study details as provided by Galapagos NV:

Primary Outcome 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 Outcome 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


Enrollment: 36
Study Start Date: July 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40-50 years old
GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
Drug: GLPG0634 100mg capsule once a day for 10 days
Experimental: 65-74 years old
GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old
Drug: GLPG0634 100mg capsule once a day for 10 days
Experimental: 75 years and older
GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older
Drug: GLPG0634 100mg capsule once a day for 10 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665924


Locations
Belgium
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Belgium, 2060
Sponsors and Collaborators
Galapagos NV
Investigators
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Principal Investigator: Magdalena Petkova, MD SGS LSS Clinical Pharmacology Unit Antwerp
  More Information

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01665924     History of Changes
Other Study ID Numbers: GLPG0634-CL-104
First Submitted: August 14, 2012
First Posted: August 16, 2012
Last Update Posted: March 28, 2013
Last Verified: March 2013