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
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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


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 ] [ 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


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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01665924     History of Changes
Other Study ID Numbers: GLPG0634-CL-104
Study First Received: August 14, 2012
Last Updated: March 26, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

ClinicalTrials.gov processed this record on September 18, 2014