Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects - Full Text View

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

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 May 19, 2013