HealthyPhase 1NCT05272683
Drug-drug Interaction Study with GLPG3667 and Itraconazole in Healthy Subjects
A Phase 1 study testing GLPG3667 and Itraconazole in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Canada.
Trial summary
The main purpose of this study is to determine the effect of itraconazole on the amount of GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when GLPG3667 is administered alone. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG3667 and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2022to 22 Apr 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level in the postmenopausal range. For surgical sterilization, documented confirmation will be requested.
- A body mass index between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.
- This list only contains the key inclusion criteria.
Who cannot join
- Known hypersensitivity to ingredients of GLPG3667 and/or itraconazole, or history of a significant allergic reaction to ingredients of GLPG3667 and/or itraconazole, as determined by the investigator.
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
- This list only contains the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed-sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of Itraconazole, a Strong CYP3A4 Inhibitor and Potent P-gp Inhibitor on the Pharmacokinetics of GLPG3667
The main purpose of this study is to determine the effect of itraconazole on the amount of GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when GLPG3667 is administered alone.
- Conditions
- Healthy
- Being tested
- GLPG3667, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3667Drug
On day 1 and day 8, participants will receive a single dose
ItraconazoleDrug
On days 5 to 11, participants will receive itraconazole once daily
| Study group | Role | What they receive |
|---|---|---|
| GLPG3667 + itraconazole | Experimental | Not described Receives: Drug: GLPG3667; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of GLPG3667
To determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667
Measured: From Day 1 pre-dose until Day 12
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of GLPG3667
To determine the effect of itraconazole on the PK of GLPG3667
Measured: From Day 1 pre-dose until Day 12
Secondary outcomes (1)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation.
To evaluate the safety and tolerability of GLPG3667 alone or when co-administered with itraconazole
Measured: From Day 1 through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start28 Feb 2022
- Primary completion1 Apr 2022
- Study completion22 Apr 2022
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272683
- Sponsor's protocol ID
- GLPG3667-CL-109
- Status last verified
- May 2022
- First submitted
- 28 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed-sequence, Drug-drug Interaction Study in Healthy Subjects to Evaluate the Effect of Itraconazole, a Strong CYP3A4 Inhibitor and Potent P-gp Inhibitor on the Pharmacokinetics of GLPG3667
- ClinicalTrials.gov ID
- NCT05272683
- Acronym / sponsor ID
- GLPG3667-CL-109
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 9 Mar 2022 (actual)
- 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 main purpose of this study is to determine the effect of itraconazole on the amount of GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when GLPG3667 is administered alone.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLPG3667 + itraconazole | Experimental | Drug: GLPG3667, Drug: Itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF). Female subjects should be of non-childbearing potential, defined as permanently surgically sterile (bilateral oophorectomy, i.e. surgical removal of ovaries, bilateral salpingectomy or hysterectomy, i.e. surgical removal of uterus), or with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level in the postmenopausal range. For surgical sterilization, documented confirmation will be requested.
- A body mass index between 18.0 and 30.0 kg/m2, inclusive.
- Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests. Neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal ranges need to be considered not clinically significant in the opinion of the investigator.
- This list only contains the key inclusion criteria.
Key exclusion criteria (3 listed)
- Known hypersensitivity to ingredients of GLPG3667 and/or itraconazole, or history of a significant allergic reaction to ingredients of GLPG3667 and/or itraconazole, as determined by the investigator.
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements, and hormonal replacement therapy) except occasional paracetamol (maximum dose of 2 g/day and maximum of 10 g/2 weeks) in the last 2 weeks or 5 half-lives of the drug, whichever is longer, prior to the first dosing.
- This list only contains the key exclusion criteria.
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 |
|---|---|---|
| GLPG3667On day 1 and day 8, participants will receive a single dose | Drug | GLPG3667 + itraconazole |
| ItraconazoleOn days 5 to 11, participants will receive itraconazole once daily | Drug | GLPG3667 + itraconazole |
Primary outcome
Maximum observed plasma concentration (Cmax) of GLPG3667
Time frame: From Day 1 pre-dose until Day 12
To determine the effect of itraconazole on the pharmacokinetics (PK) of GLPG3667
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of GLPG3667
Time frame: From Day 1 pre-dose until Day 12
To determine the effect of itraconazole on the PK of GLPG3667
1 secondary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuation.
Time frame: From Day 1 through study completion, an average of 2 months
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 19 Sep 2024.
- 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.
Galapagos Study Director, 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 GLPG3667 and Itraconazole in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Canada.
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 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 19 Sep 2024. 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 Canada. 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?
Maximum observed plasma concentration (Cmax) of GLPG3667 (time frame: From Day 1 pre-dose until Day 12). 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 19 Sep 2024.