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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GLPG0634 100mg capsule once a day for 10 days

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2060
    • SGS LSS Clinical Pharmacology Unit Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634	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	From predose (before first study drug administration) up to 72 hours post last study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634	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	From predose (before first study drug administration) up to 24 hours post last study drug administration
Number of adverse events	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	From screening up to 10 days after the last study drug administration
Changes in vital signs as measured by heart rate, blood pressure and body temperature	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	From screening up to 10 days after the last study drug administration
Changes in 12-lead ECG measures	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	From screening up to 10 days after the last study drug administration
Changes in physical exam measures	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	From screening up to 10 days after the last study drug administration
Changes in blood safety lab parameters	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	From screening up to 10 days after the last study drug administration
Changes in urine safety lab parameters	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	From screening up to 10 days after the last study drug administration

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Principal Investigator: Magdalena Petkova, MD, SGS LSS Clinical Pharmacology Unit Antwerp

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 26, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: GLPG0634-CL-104