HealthyPhase 1NCT01580644
Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers
A Phase 1 study testing GLPG0187 prodrug in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG0187 prodrug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2012to Mar 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 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, age 18-50 years
- 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.
About this study
Official title: Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects
The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.
Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.
Furthermore, during the course of the study, safety and tolerability will be characterized.
- Conditions
- Healthy
- Being tested
- GLPG0187 prodrug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0187 prodrugDrug
| Study group | Role | What they receive |
|---|---|---|
| Period 1: formulation 1 oral solution | Experimental | Not described Receives: Drug: GLPG0187 prodrug |
| Period 2: formulation 2 capsule | Experimental | Not described Receives: Drug: GLPG0187 prodrug |
| Period 3: Selected formulation + food | Experimental | Not described Receives: Drug: GLPG0187 prodrug |
| Period 4: Selected formulation at higher dose | Experimental | Not described Receives: Drug: GLPG0187 prodrug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects
Secondary outcomes (7)
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug with food in healthy subjects
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of the selected formulation of GLPG0187 prodrug at a higher dose (with or without food) in healthy subjects to evaluate dose proportionality
Number of adverse events
To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the number of adverse events reported
Changes in vital signs as measured by heart rate, blood pressure and body temperature
To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and body temperature reported
Changes on 12-lead ECG measures
To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in 12-ECG measures reported
Changes in physical exam measures
To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of changes in physical examination reported
Changes in blood and urine safety lab parameters
To evaluate the safety and tolerability of prodrug of GLPG0187 after a single oral dose in healthy subjects in terms of the changes in blood and urine safety lab parameters assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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 NVEva Vets, MD, Principal investigator, SGS Stuivenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01580644
- Sponsor's protocol ID
- GLPG0187-CL-104
- Status last verified
- Apr 2012
- First submitted
- 18 Apr 2012
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study of Two Formulations of the Isopropyl Malonate Prodrug of GLPG0187 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01580644
- Acronym / sponsor ID
- GLPG0187-CL-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Apr 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 this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.
Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.
Furthermore, during the course of the study, safety and tolerability will be characterized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period 1: formulation 1 oral solution | Experimental | Drug: GLPG0187 prodrug |
| Period 2: formulation 2 capsule | Experimental | Drug: GLPG0187 prodrug |
| Period 3: Selected formulation + food | Experimental | Drug: GLPG0187 prodrug |
| Period 4: Selected formulation at higher dose | Experimental | Drug: GLPG0187 prodrug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male, age 18-50 years
- 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 |
|---|---|---|
| GLPG0187 prodrug | Drug | Period 1: formulation 1 oral solution, Period 2: formulation 2 capsule, Period 3: Selected formulation + food, Period 4: Selected formulation at higher dose |
Primary outcome
The amount of GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug
To characterize the amount of GLPG0187 in plasma over time - pharmacokinetics (PK) - after a single oral dose of either of 2 formulations of GLPG0187 prodrug in healthy subjects
7 secondary outcomes
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug with food
The amount of GLPG0187 in plasma over time after a single oral dose of the best formulation of GLPG0187 prodrug at a higher dose (with or without food)
Number of adverse events
Changes in vital signs as measured by heart rate, blood pressure and body temperature
Changes on 12-lead ECG measures
Changes in physical exam measures
Changes in blood and urine safety lab parameters
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 20 Apr 2012.
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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
Eva Vets, MD principal investigator
SGS Stuivenberg
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 GLPG0187 prodrug 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 20 Apr 2012. 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 GLPG0187 in plasma over time after a single oral dose of either of 2 formulations of GLPG0187 prodrug. 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 20 Apr 2012.