HealthyPhase 1NCT01665924
Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
A Phase 1 study testing GLPG0634 100mg capsule once a day for 10 days in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG0634 100mg capsule once a day for 10 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2012to Oct 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female, age 40 years and older
- BMI between 18-30 kg/m2
Who cannot join
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS LSS Clinical Pharmacology Unit Antwerp
Antwerp, Antwerp, 2060
About this study
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.
- Conditions
- Healthy
- Being tested
- GLPG0634 100mg capsule once a day for 10 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0634 100mg capsule once a day for 10 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| 40-50 years old | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old Receives: Drug: GLPG0634 100mg capsule once a day for 10 days |
| 65-74 years old | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old Receives: Drug: GLPG0634 100mg capsule once a day for 10 days |
| 75 years and older | Experimental | GLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older Receives: Drug: GLPG0634 100mg capsule once a day for 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From predose (before first study drug administration) up to 72 hours post last study drug administration
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From screening up to 10 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Vanhoutte, MD, Study director, Lakefront Biotherapeutics NVMagdalena Petkova, MD, Principal investigator, SGS LSS Clinical Pharmacology Unit Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665924
- Sponsor's protocol ID
- GLPG0634-CL-104
- Status last verified
- Mar 2013
- First submitted
- 14 Aug 2012
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Multiple Dose Pharmacokinetics of GLPG0634 in Elderly Healthy Subjects
- ClinicalTrials.gov ID
- NCT01665924
- Acronym / sponsor ID
- GLPG0634-CL-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40-50 years old | Experimental | Drug: GLPG0634 100mg capsule once a day for 10 daysGLPG0634 100mg capsule once a day for 10 days in healthy subjects between 40 and 50 years old |
| 65-74 years old | Experimental | Drug: GLPG0634 100mg capsule once a day for 10 daysGLPG0634 100mg capsule once a day for 10 days in healthy subjects between 65 and 74 years old |
| 75 years and older | Experimental | Drug: GLPG0634 100mg capsule once a day for 10 daysGLPG0634 100mg capsule once a day for 10 days in healthy subjects of 75 years and older |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy male or female, age 40 years and older
- BMI between 18-30 kg/m2
Key exclusion criteria (3 listed)
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLPG0634 100mg capsule once a day for 10 days | Drug | 40-50 years old, 65-74 years old, 75 years and older |
Primary outcome
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
7 secondary outcomes
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
Number of adverse events
Time frame: 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
Time frame: From screening up to 10 days after the last study drug administration
Changes in 12-lead ECG measures
Time frame: From screening up to 10 days after the last study drug administration
Changes in physical exam measures
Time frame: From screening up to 10 days after the last study drug administration
Changes in blood safety lab parameters
Time frame: From screening up to 10 days after the last study drug administration
Changes in urine safety lab parameters
Time frame: From screening up to 10 days after the last study drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Vanhoutte, MD study director
Lakefront Biotherapeutics NV
Magdalena Petkova, MD principal investigator
SGS LSS Clinical Pharmacology Unit Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG0634 100mg capsule once a day for 10 days in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2013.