Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Healthy Clinical Trial

Official title:

Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665924
• Other study ID #: GLPG0634-CL-104
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2012
• Last updated: March 26, 2013
• Start date: July 2012
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes