HealthyPhase 1NCT01419990
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects
A Phase 1 study testing GLPG0634 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 of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of… 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?
- GLPG0634
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to Oct 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 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: Double-blind Placebo Controlled Dose-ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Oral Dosing of GLPG0634 in Healthy Subjects
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.
During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.
- Conditions
- Healthy
- Being tested
- GLPG0634, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG0634Drug
GLPG0634 300 mg oral capsules, qd, 10 days
GLPG0634Drug
GLPG0634 450 mg oral capsules, qd, 10 days
PlaceboDrug
Placebo oral capsules, qd, 10 days
| Study group | Role | What they receive |
|---|---|---|
| GLPG0634 capsules | Experimental | Not described Receives: Drug: GLPG0634 |
| Placebo capsules | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
Measured: From screening up to 10 days after the last dose
Secondary outcomes (1)
Pharmacokinetics (PK) and pharmacodynamics (PD)
To determine the plasma levels of GLPG0634 as a measure of PK and the levels of immune- and inflammation-related parameters as a measure of PD
Measured: From first dose up to 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 posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 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 NVLien Gheyle, MD, Principal investigator, SGS Stuivenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419990
- Sponsor's protocol ID
- GLPG0634-CL-102
- Status last verified
- Aug 2012
- First submitted
- 17 Aug 2011
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.
PubMed 25681059
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. 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 Dosing of GLPG0634 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01419990
- Acronym / sponsor ID
- GLPG0634-CL-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Aug 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 of GLPG0634 given to healthy subjects for 10 days compared to placebo.
During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG0634 capsules | Experimental | Drug: GLPG0634 |
| Placebo capsules | Placebo comparator | Drug: Placebo |
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 |
|---|---|---|
| GLPG0634GLPG0634 300 mg oral capsules, qd, 10 days | Drug | GLPG0634 capsules |
| GLPG0634GLPG0634 450 mg oral capsules, qd, 10 days | Drug | GLPG0634 capsules |
| PlaceboPlacebo oral capsules, qd, 10 days | Drug | Placebo capsules |
Primary outcome
Safety and tolerability
Time frame: From screening up to 10 days after the last dose
To evaluate the safety and tolerability of GLPG0634 in comparison with placebo after multiple oral doses in healthy subjects in terms of adverse events, physical examinations, vital signs, ECG and lab assessments
1 secondary outcome
Pharmacokinetics (PK) and pharmacodynamics (PD)
Time frame: From first dose up to 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 15 Aug 2012.
- Derived from this study: PubMed 25681059Namour F, Diderichsen PM, Cox E, Vayssiere B, Van der Aa A, Tasset C, Van't Klooster G. Pharmacokinetics and Pharmacokinetic/Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection. Clin Pharmacokinet. 2015 Aug;54(8):859-74. doi: 10.1007/s40262-015-0240-z.
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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
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 GLPG0634 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 15 Aug 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. 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 (time frame: From screening up to 10 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419990, which also lists 1 linked publication.
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 15 Aug 2012.