HealthyPhase 1NCT01208753
Pharmacokinetics/Pharmacodynamics (PK/PD) of Multiple Oral Doses of GLPG0555 in Healthy Subjects
A Phase 1 study testing GLPG0555 and GLPG0555 aqueous 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 safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3… 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 and GLPG0555 aqueous
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Feb 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, age 18-50 years
- 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: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
- Conditions
- Healthy
- Being tested
- GLPG0555, GLPG0555 aqueous, placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0555Drug
two different aqueous formulations
GLPG0555 aqueousDrug
multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
placeboDrug
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
| Study group | Role | What they receive |
|---|---|---|
| Aqueous formulations for formulation selection | Experimental | 50 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation Receives: Drug: GLPG0555 |
| GLPG0555 ascending doses | Experimental | multiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily) Receives: Drug: GLPG0555 aqueous |
| 3 | Placebo comparator | once or twice daily for 13 days, matching the scheme of the multiple ascending dose. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of multiple dosing
Measured: Daily during treatment, up to 10 days postdose
Secondary outcomes (3)
Pharmacokinetics of repeated doses
Measured: 24 hours postdose
Pharmacodynamics (PD) of GLPG0555 after repeated oral administration
Measured: up to 10 days postdose
The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days
Measured: up to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionFeb 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 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 NVWouter Haazen, MD, Principal investigator, SGS Stuivenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208753
- Sponsor's protocol ID
- GLPG0555-CL-102
- Other IDs
- 2010-018570-20
- Status last verified
- Mar 2011
- First submitted
- 23 Sep 2010
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Doses of GLPG0555 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01208753
- Acronym / sponsor ID
- GLPG0555-CL-102
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Sep 2010 (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 safety and tolerability of multiple ascending oral doses (MAD) of GLPG0555 given to healthy subjects for 13 days compared to placebo, and to evaluate the relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions of GLPG0555 administered for 3 days. Finally, it is aimed to characterize PK and pharmacodynamics (PD) of GLPG0555 after multiple oral administrations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aqueous formulations for formulation selection | Experimental | Drug: GLPG055550 mg once daily for 3 days of two different aqueous suspensions, with four day wash-out between formulation |
| GLPG0555 ascending doses | Experimental | Drug: GLPG0555 aqueousmultiple ascending doses for 13 days, ranging from 100 mg once daily upto a maximum to be determined during escalation (given as once or twice daily) |
| 3 | Placebo comparator | Drug: placeboonce or twice daily for 13 days, matching the scheme of the multiple ascending dose. |
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, 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 |
|---|---|---|
| GLPG0555two different aqueous formulations | Drug | Aqueous formulations for formulation selection |
| GLPG0555 aqueousmultiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined | Drug | GLPG0555 ascending doses |
| placebomultiple dose, aqueous formulation, 13 days days, matching ascending dose schedule | Drug | 3 |
Primary outcome
Safety and tolerability of multiple dosing
Time frame: Daily during treatment, up to 10 days postdose
3 secondary outcomes
Pharmacokinetics of repeated doses
Time frame: 24 hours postdose
Pharmacodynamics (PD) of GLPG0555 after repeated oral administration
Time frame: up to 10 days postdose
The relative bioavailability and pharmacokinetics (PK) of two different aqueous suspensions administered for three days
Time frame: up to 24 hours 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 23 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
Wouter Haazen, 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 and GLPG0555 aqueous 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 23 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability of multiple dosing (time frame: Daily during treatment, up to 10 days postdose). 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 23 Mar 2011.