HealthyPhase 1NCT02662452
First-in-Human Single and Multiple Dose of GLPG2222
A Phase 1 study testing GLPG2222 single dose and GLPG2222 multiple 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 GLPG2222 given to healthy subjects, compared to placebo (Part 1). 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?
- GLPG2222 single dose and GLPG2222 multiple doses
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to May 2016
- 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
- Males between 18-50 years of age
- Subjects must have a body mass index between 18-30 kg/m²
- 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 profile
- Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)
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
- 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 must be used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.
The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.
- Conditions
- Healthy
- Being tested
- GLPG2222 single dose, Placebo single dose, GLPG2222 multiple doses, Placebo multiple doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG2222 single doseDrug
single ascending doses, oral suspension
Placebo single doseDrug
single doses, oral suspension, matching placebo
GLPG2222 multiple dosesDrug
multiple ascending 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 |
|---|---|---|
| GLPG2222 single dose | Experimental | Single dose of GLPG2222 oral suspension Receives: Drug: GLPG2222 single dose |
| Placebo single dose | Placebo comparator | Single dose of placebo oral suspension Receives: Drug: Placebo single dose |
| GLPG2222 multiple doses | Experimental | Multiple doses of GLPG2222 oral suspension Receives: Drug: GLPG2222 multiple doses |
| Placebo multiple doses | Placebo comparator | Multiple doses of placebo oral suspension Receives: Drug: Placebo multiple doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change versus placebo in number of subjects with adverse events
To evaluate the safety and tolerability of GLPG2222 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
Change versus placebo in number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG2222 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
Change versus placebo in number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG2222 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
Change versus placebo in number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram
Measured: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG2222 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
Change versus placebo in number of subjects with abnormal pulmonary function
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry
Measured: Between screening and 4 days after the last dose (Part 1 only)
Secondary outcomes (3)
The amount of GLPG2222 in plasma
To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Measured: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG2222 in urine
To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
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 interaction after repeated oral dosing with GLPG2222 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 posted25 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionApr 2016
- Study completionMay 2016
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kirsteen Donaldson, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662452
- Sponsor's protocol ID
- GLPG2222-CL-101
- Other IDs
- 2015-004466-29, 2015
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, First-in-Human Study of GLPG2222 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02662452
- Acronym / sponsor ID
- GLPG2222-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jan 2016 (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 GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.
The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 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 |
|---|---|---|
| GLPG2222 single dose | Experimental | Drug: GLPG2222 single doseSingle dose of GLPG2222 oral suspension |
| Placebo single dose | Placebo comparator | Drug: Placebo single doseSingle dose of placebo oral suspension |
| GLPG2222 multiple doses | Experimental | Drug: GLPG2222 multiple dosesMultiple doses of GLPG2222 oral suspension |
| Placebo multiple doses | Placebo comparator | Drug: Placebo multiple dosesMultiple doses of placebo oral suspension |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males between 18-50 years of age
- Subjects must have a body mass index between 18-30 kg/m²
- 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 profile
- Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)
Key exclusion criteria (4 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
- 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 must be used
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 |
|---|---|---|
| GLPG2222 single dosesingle ascending doses, oral suspension | Drug | GLPG2222 single dose |
| Placebo single dosesingle doses, oral suspension, matching placebo | Drug | Placebo single dose |
| GLPG2222 multiple dosesmultiple ascending doses, daily for 14 days, oral suspension | Drug | GLPG2222 multiple doses |
| Placebo multiple dosesmultiple doses, daily for 14 days, oral suspension, matching placebo | Drug | Placebo multiple doses |
Primary outcome
Change versus placebo in 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Change versus placebo in 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Change versus placebo in 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Change versus placebo in 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram
Change versus placebo in 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 GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
Change versus placebo in number of subjects with abnormal pulmonary function
Time frame: Between screening and 4 days after the last dose (Part 1 only)
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry
3 secondary outcomes
The amount of GLPG2222 in plasma
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG2222 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 29 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Kirsteen Donaldson, 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 GLPG2222 single dose and GLPG2222 multiple 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 4 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 29 Jul 2016. 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?
Change versus placebo in number of subjects with adverse events (time frame: Between screening and 7-10 days after the last dose). The study lists 6 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 29 Jul 2016.