Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT01665924
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Primary Completion: 2012-09
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-26
• Last Update Posted: 2013-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634	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

Name	Time	Method
The amount of GLPG0634 mechanism-of-action-related biomarkers in blood after multiple doses of GLPG0634	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	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	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	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	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	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	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

Trial Locations

Locations (1)

SGS LSS Clinical Pharmacology Unit Antwerp; 🇧🇪 Antwerp, Belgium