HealthyPhase 1NCT02325037
First-in-Human Single and Multiple Dose of GLPG1837
A Phase 1 study testing GLPG1837 single ascending doses and GLPG1837 multiple ascending doses in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG1837 single ascending doses and GLPG1837 multiple ascending doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Sep 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females of non-child bearing potential between 18-50 years of age (included)
- Subjects must have a body mass index between 18-30 kg/m² (included)
- Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory findings
Who cannot join
- A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration
- A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
- Current sexually active (and/or child wish) male; a contraception method should be used
- Pregnant or lactating women or women of childbearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG1837 in Healthy Subjects
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.
Read more
The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.
The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.
- Conditions
- Healthy
- Being tested
- GLPG1837 single ascending doses, Placebo single dose, GLPG1837 multiple ascending doses, Placebo multiple doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1837 single ascending dosesDrug
Single dose, oral suspension
Placebo single doseDrug
Single dose, oral suspension matching placebo
GLPG1837 multiple ascending dosesDrug
Multiple doses, daily for 14 days, oral suspension
Placebo multiple dosesDrug
Multiple doses, daily for 14 days, oral suspension, matching placebo
| Study group | Role | What they receive |
|---|---|---|
| GLPG1837 single dose | Experimental | Single oral dose of GLPG1837 suspension - ascending doses Receives: Drug: GLPG1837 single ascending doses |
| Placebo single dose | Placebo comparator | Single oral dose of placebo suspension Receives: Drug: Placebo single dose |
| GLPG1837 muliple doses | Experimental | Multiple oral doses of GLPG1837 suspension - ascending doses Receives: Drug: GLPG1837 multiple ascending doses |
| Placebo multiple doses | Placebo comparator | Multiple oral doses of placebo suspension Receives: Drug: Placebo multiple doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
Measured: Between screening and 7-10 days after the last dose
Number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
Measured: Between screening and 7-10 days after the last dose
Secondary outcomes (3)
The amount of GLPG1837 and its metabolite in plasma
To characterize the amount of GLPG1837 and its metabolite in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed
Measured: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG1837 and its metabolite in urine
To characterize the amount of GLPG1837 and its metabolite in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects, fasted or fed
Measured: Between Day 1 predose and 24 hours after the (last) dose
Ratio of 6-b-hydroxycortisol/cortisol in urine
To assess the potential of CYP3A4 induction after repeated oral dosing with GLPG1837 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
Measured: Twelve hours before dosing on Day 1 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2015
- Study completionSep 2015
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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 NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325037
- Sponsor's protocol ID
- GLPG1837-CL-101
- Other IDs
- 2014-003853-32, 2014
- Status last verified
- Sep 2015
- First submitted
- 19 Dec 2014
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG1837 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02325037
- Acronym / sponsor ID
- GLPG1837-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 24 Dec 2014 (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 this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.
The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.
The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG1837 single dose | Experimental | Drug: GLPG1837 single ascending dosesSingle oral dose of GLPG1837 suspension - ascending doses |
| Placebo single dose | Placebo comparator | Drug: Placebo single doseSingle oral dose of placebo suspension |
| GLPG1837 muliple doses | Experimental | Drug: GLPG1837 multiple ascending dosesMultiple oral doses of GLPG1837 suspension - ascending doses |
| Placebo multiple doses | Placebo comparator | Drug: Placebo multiple dosesMultiple oral doses of placebo suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Males or females of non-child bearing potential between 18-50 years of age (included)
- Subjects must have a body mass index between 18-30 kg/m² (included)
- Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory findings
Key exclusion criteria (5 listed)
- A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
- Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study or participation within 15 weeks prior to initial study drug administration in an investigational research study with antibody administration
- A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
- Current sexually active (and/or child wish) male; a contraception method should be used
- Pregnant or lactating women or women of childbearing potential
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 |
|---|---|---|
| GLPG1837 single ascending dosesSingle dose, oral suspension | Drug | GLPG1837 single dose |
| Placebo single doseSingle dose, oral suspension matching placebo | Drug | Placebo single dose |
| GLPG1837 multiple ascending dosesMultiple doses, daily for 14 days, oral suspension | Drug | GLPG1837 muliple doses |
| Placebo multiple dosesMultiple doses, daily for 14 days, oral suspension, matching placebo | Drug | Placebo multiple doses |
Primary outcome
Number of subjects with adverse events
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Number of subjects with abnormal laboratory parameters
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Number of subjects with abnormal vital signs
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Number of subjects with abnormal electrocardiogram
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiograms
Number of subjects with abnormal physical examination
Time frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG1837 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
3 secondary outcomes
The amount of GLPG1837 and its metabolite in plasma
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG1837 and its metabolite in urine
Time frame: Between Day 1 predose and 24 hours after the (last) dose
Ratio of 6-b-hydroxycortisol/cortisol in urine
Time frame: Twelve hours before dosing on Day 1 and Day 14
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 9 Sep 2015.
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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
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 GLPG1837 single ascending doses and GLPG1837 multiple ascending doses 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 3 inclusion and 5 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 9 Sep 2015. 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?
Number of subjects with adverse events (time frame: Between screening and 7-10 days after the last dose). The study lists 5 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 9 Sep 2015.