Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Galapagos NV
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The amount of GLPG0634 in plasma over time after single and multiple doses of GLPG0634
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
40-50 years old
GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old
Intervention: GLPG0634 100mg capsule once a day for 10 days (Drug)
65-74 years old
GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old
Intervention: GLPG0634 100mg capsule once a day for 10 days (Drug)
75 years and older
GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older
Intervention: GLPG0634 100mg capsule once a day for 10 days (Drug)
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)
- Number of adverse events(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(From screening up to 10 days after the last study drug administration)
- Changes in 12-lead ECG measures(From screening up to 10 days after the last study drug administration)
- Changes in physical exam measures(From screening up to 10 days after the last study drug administration)
- Changes in blood safety lab parameters(From screening up to 10 days after the last study drug administration)
- Changes in urine safety lab parameters(From screening up to 10 days after the last study drug administration)