HealthyPhase 1NCT01336244
GLPG0778: Multiple Ascending Oral Doses, Pharmacokinetic, Safety, and Pharmacodynamic Study
A Phase 1 study testing GLPG0778 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 GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations. 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?
- GLPG0778
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2011to Sep 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
- body mass index (BMI) between 18-30 kg/m², inclusive.
Who cannot join
- significantly abnormal platelet function or coagulopathy
- smoking
- drug or alcohol abuse
- hypersensitivity to any of the test substances
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 Ascending Oral Doses of GLPG0778 in Healthy Male Subjects
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
- Conditions
- Healthy
- Being tested
- GLPG0778, placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0778Drug
capsules containing 50 or 100 mg of GLPG0778
placeboDrug
multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
| Study group | Role | What they receive |
|---|---|---|
| GLPG0778 ascending doses | Experimental | Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation. Receives: Drug: GLPG0778 |
| Placebo | Placebo comparator | 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.
Occurrence of adverse events
At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
Measured: Daily during treatment, up to 10 days postdose
Evaluation of hematological, biochemical and cardiovascular parameters.
On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
Measured: until 10 days postdose.
Secondary outcomes (2)
Pharmacokinetics of repeated doses
Bloodsamples are taken on various timepoints to assess how much of the study drug is taken up in the blood (absorption), how long it stays in the blood (excretion), and whether any "breakdown"-products of the drug are present (metabolism).
Measured: 24 hours postdose
Pharmacodynamics (PD) of GLPG0778
To explore biomarkers of GLPG0778 activity after repeated oral administrations.
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 posted15 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionSep 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerben van 't Klooster, PhD, Study director, Lakefront Biotherapeutics NVLien Gheyle, MD, Principal investigator, SGS Stuivenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336244
- Sponsor's protocol ID
- GLPG0778-CL-102
- Other IDs
- 2011-000892-16
- Status last verified
- Oct 2011
- First submitted
- 13 Apr 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 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 Ascending Oral Doses of GLPG0778 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01336244
- Acronym / sponsor ID
- GLPG0778-CL-102
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Apr 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 evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG0778 ascending doses | Experimental | Drug: GLPG0778Multiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation. |
| Placebo | Placebo comparator | Drug: placeboTwice 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
- body mass index (BMI) between 18-30 kg/m², inclusive.
Key exclusion criteria (4 listed)
- significantly abnormal platelet function or coagulopathy
- smoking
- drug or alcohol abuse
- hypersensitivity to any of the test substances
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 |
|---|---|---|
| GLPG0778capsules containing 50 or 100 mg of GLPG0778 | Drug | GLPG0778 ascending doses |
| placebomultiple dose, aqueous formulation, 13 days days, matching ascending dose schedule | Drug | Placebo |
Primary outcome
Occurrence of adverse events
Time frame: Daily during treatment, up to 10 days postdose
At every study visit, subjects will be asked whether any adverse events have occurred since start of treatment.
Evaluation of hematological, biochemical and cardiovascular parameters.
Time frame: until 10 days postdose.
On predefined timepoints during the study blood and urine samples will be taken, and cardiovascular tests (ECG, blood pressure, heart rate) recorded to assess whether the test compound causes any deviation.
2 secondary outcomes
Pharmacokinetics of repeated doses
Time frame: 24 hours postdose
Pharmacodynamics (PD) of GLPG0778
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 18 Oct 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
Lien Gheyle, 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 GLPG0778 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 4 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 18 Oct 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?
Occurrence of adverse events (time frame: Daily during treatment, up to 10 days postdose). The study lists 2 primary outcomes in all. 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 18 Oct 2011.