HealthyPhase 1NCT01915667
Oral Bioavailability of Two Solid Formulations of GLPG0634
A Phase 1 study testing 200 mg GLPG0634 as capsules, fasted, 200 mg GLPG0634 as tablets, fasted and 200 mg GLPG0634 as tablets, fed 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 (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 200 mg GLPG0634 as capsules, fasted, 200 mg GLPG0634 as tablets, fasted and 200 mg GLPG0634 as tablets, fed
- 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
- Jul 2013to Sep 2013
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, age 40-60 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 Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects
The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.
Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.
- Conditions
- Healthy
- Being tested
- 200 mg GLPG0634 as capsules, fasted, 200 mg GLPG0634 as tablets, fasted, 200 mg GLPG0634 as tablets, fed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg GLPG0634 as capsules, fastedDrug
single oral dose of 200 mg GLPG0634 given as capsules in fasted condition
200 mg GLPG0634 as tablets, fastedDrug
single oral dose of 200 mg GLPG0634 given as tablets in fasted condition
200 mg GLPG0634 as tablets, fedDrug
single oral dose of 200 mg GLPG0634 given as tablets in fed condition
| Study group | Role | What they receive |
|---|---|---|
| GLPG0634 capsule fasted | Experimental | Single dose of GLPG0634 as capsules in fasted condition Receives: Drug: 200 mg GLPG0634 as capsules, fasted |
| GLPG0634 tablet fasted | Experimental | Single dose of GLPG0634 as tablets in fasted condition Receives: Drug: 200 mg GLPG0634 as tablets, fasted |
| GLPG0634 tablet fed | Active comparator | Single dose of GLPG0634 as tablets in fed condition Receives: Drug: 200 mg GLPG0634 as tablets, fed |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.
Measured: From predose (before first study drug administration) up to 144 hours post last study drug administration
Secondary outcomes (1)
The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets
To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG)
Measured: Between screening and 7-10 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013
- Study completionSep 2013
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
- 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
- Pille Harrison, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915667
- Sponsor's protocol ID
- GLPG0634-CL-107
- Status last verified
- Sep 2013
- First submitted
- 2 Aug 2013
- Last updated
- 17 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01915667
- Acronym / sponsor ID
- GLPG0634-CL-107
- 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
- Jul 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Aug 2013 (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 (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.
Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLPG0634 capsule fasted | Experimental | Drug: 200 mg GLPG0634 as capsules, fastedSingle dose of GLPG0634 as capsules in fasted condition |
| GLPG0634 tablet fasted | Experimental | Drug: 200 mg GLPG0634 as tablets, fastedSingle dose of GLPG0634 as tablets in fasted condition |
| GLPG0634 tablet fed | Active comparator | Drug: 200 mg GLPG0634 as tablets, fedSingle dose of GLPG0634 as tablets in fed condition |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male, age 40-60 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 |
|---|---|---|
| 200 mg GLPG0634 as capsules, fastedsingle oral dose of 200 mg GLPG0634 given as capsules in fasted condition | Drug | GLPG0634 capsule fasted |
| 200 mg GLPG0634 as tablets, fastedsingle oral dose of 200 mg GLPG0634 given as tablets in fasted condition | Drug | GLPG0634 tablet fasted |
| 200 mg GLPG0634 as tablets, fedsingle oral dose of 200 mg GLPG0634 given as tablets in fed condition | Drug | GLPG0634 tablet fed |
Primary outcome
The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
Time frame: From predose (before first study drug administration) up to 144 hours post last study drug administration
To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.
1 secondary outcome
The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets
Time frame: Between screening and 7-10 days after the last dose
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 17 Sep 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.
Pille Harrison, MD study director
Lakefront Biotherapeutics NV
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 200 mg GLPG0634 as capsules, fasted, 200 mg GLPG0634 as tablets, fasted and 200 mg GLPG0634 as tablets, fed 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 17 Sep 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 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets (time frame: From predose (before first study drug administration) up to 144 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 17 Sep 2013.