HealthyPhase 1NCT01278095
Oral Bioavailability of GLPG0555 in Different Solid Formulations
A Phase 1 study testing GLPG0555 solid dispersion and GLPG0555 nanosuspension in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555. 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?
- GLPG0555 solid dispersion and GLPG0555 nanosuspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Mar 2011
- 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
- BMI between 18-30 kg/m², inclusive.
Who cannot join
- significantly abnormal platelet function or coagulopathy
- smoking
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation
The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.
- Conditions
- Healthy
- Being tested
- GLPG0555 solid dispersion, GLPG0555 nanosuspension
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0555 solid dispersionDrug
solid dispersion capsules, 50 mg, single dose
GLPG0555 nanosuspensionDrug
Nanosuspension, 50 mg, single dose
| Study group | Role | What they receive |
|---|---|---|
| GLPG0555 solid dispersion, fasting | Experimental | 50 mg as solid dispersion capsule, in fasting condition Receives: Drug: GLPG0555 solid dispersion |
| GLPG0555 solid dispersion, fed | Experimental | 50 mg as solid dispersion capsule, after breakfast Receives: Drug: GLPG0555 solid dispersion |
| GLPG0555 nanosuspension, fed | Experimental | 50 mg as nanosuspension, given after breakfast Receives: Drug: GLPG0555 nanosuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability of solid formulation
Measured: 72 hrs
Secondary outcomes (1)
Safety and tolerability of single doses of GLPG0555
Measured: up to 10 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2011
- Study completionMar 2011
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerben van 't Klooster, PhD, Study director, Lakefront Biotherapeutics NVJos Leempoels, MD, Principal investigator, SGS Stuivenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278095
- Sponsor's protocol ID
- GLPG0555-CL-103
- Other IDs
- 2010-022457-42
- Status last verified
- Mar 2011
- First submitted
- 14 Jan 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation
- ClinicalTrials.gov ID
- NCT01278095
- Acronym / sponsor ID
- GLPG0555-CL-103
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Jan 2011 (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 compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG0555 solid dispersion, fasting | Experimental | Drug: GLPG0555 solid dispersion50 mg as solid dispersion capsule, in fasting condition |
| GLPG0555 solid dispersion, fed | Experimental | Drug: GLPG0555 solid dispersion50 mg as solid dispersion capsule, after breakfast |
| GLPG0555 nanosuspension, fed | Experimental | Drug: GLPG0555 nanosuspension50 mg as nanosuspension, given after breakfast |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy male
- BMI between 18-30 kg/m², inclusive.
Key exclusion criteria (3 listed)
- significantly abnormal platelet function or coagulopathy
- smoking
- drug or alcohol abuse
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 |
|---|---|---|
| GLPG0555 solid dispersionsolid dispersion capsules, 50 mg, single dose | Drug | GLPG0555 solid dispersion, fasting, GLPG0555 solid dispersion, fed |
| GLPG0555 nanosuspensionNanosuspension, 50 mg, single dose | Drug | GLPG0555 nanosuspension, fed |
Primary outcome
Bioavailability of solid formulation
Time frame: 72 hrs
1 secondary outcome
Safety and tolerability of single doses of GLPG0555
Time frame: up to 10 days postdose
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 24 Mar 2011.
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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.
Gerben van 't Klooster, PhD study director
Lakefront Biotherapeutics NV
Jos Leempoels, 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 GLPG0555 solid dispersion and GLPG0555 nanosuspension 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 24 Mar 2011. 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?
Bioavailability of solid formulation (time frame: 72 hrs). 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 24 Mar 2011.