Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galapagos NV
ClinicalTrials.gov Identifier:
NCT01665924
First received: August 14, 2012
Last updated: March 26, 2013
Last verified: March 2013

August 14, 2012
March 26, 2013
July 2012
September 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01665924 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 and urine safety lab parameters [ Time Frame: From screening up to 10 days after the last study drug administration ] [ Designated as safety issue: Yes ]
    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 and urine safety lab parameters assessed
Not Provided
Not Provided
 
Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: GLPG0634 100mg capsule once a day for 10 days
  • Experimental: 40-50 years old
    GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
    Intervention: 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
    Intervention: 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
    Intervention: Drug: GLPG0634 100mg capsule once a day for 10 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01665924
GLPG0634-CL-104
No
Galapagos NV
Galapagos NV
Not Provided
Study Director: Frédéric Vanhoutte, MD Galapagos NV
Principal Investigator: Magdalena Petkova, MD SGS LSS Clinical Pharmacology Unit Antwerp
Galapagos NV
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP