HealthyPhase 1NCT04097938
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667
A Phase 1 study testing GLPG3667 oral suspension and GLPG3667 capsules in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG3667 oral suspension and GLPG3667 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Sep 2019to 6 Jul 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
- A body mass index (BMI) between 18-30 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, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator
Who cannot join
- Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
- Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, 2060
About this study
Official title: A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects
This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.
- Conditions
- Healthy
- Being tested
- GLPG3667 oral suspension, Placebos, GLPG3667 capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3667 oral suspensionDrug
GLPG3667 oral suspension
PlacebosDrug
Placebo oral suspension
GLPG3667 capsulesDrug
GLPG3667 capsules
| Study group | Role | What they receive |
|---|---|---|
| GLPG3667 SAD | Experimental | Single doses of GLPG3667 at up to 6 dose levels in ascending order Receives: Drug: GLPG3667 oral suspension |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebos |
| GLPG3667 MAD | Experimental | Multiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days Receives: Drug: GLPG3667 oral suspension |
| Placebo MAD | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebos |
| GLPG3667 FE fasted | Experimental | Single dose of GLPG3667 in fasted state Receives: Drug: GLPG3667 oral suspension |
| GLPG3667 FE fed | Experimental | Single dose of GLPG3667 in fed state Receives: Drug: GLPG3667 oral suspension |
| GLPG3667 oral suspension rBA-FE fed | Experimental | Single dose of GLPG3667 oral suspension in fed state Receives: Drug: GLPG3667 oral suspension |
| GLPG3667 capsules rBA-FE fasted | Experimental | Single dose of GLPG3667 capsules in fasted state Receives: Drug: GLPG3667 capsules |
| GLPG3667 capsules rBA-FE fed | Experimental | Single dose of GLPG3667 capsules in fed state Receives: Drug: GLPG3667 capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
Measured: From screening through study completion, an average of 5 months
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3667 (μg.h/mL)
To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 (h)
To evaluate the PK of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start18 Sep 2019
- Primary completion4 Mar 2020
- Study completion6 Jul 2020
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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magdalena Petkova, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097938
- Sponsor's protocol ID
- GLPG3667-CL-101
- Other IDs
- 2019-001659-38, 2019
- Status last verified
- Jul 2020
- First submitted
- 19 Sep 2019
- 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
- A First-in-human Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3667 in Adult, Healthy, Male Subjects
- ClinicalTrials.gov ID
- NCT04097938
- Acronym / sponsor ID
- GLPG3667-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 20 Sep 2019 (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.
This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| GLPG3667 SAD | Experimental | Drug: GLPG3667 oral suspensionSingle doses of GLPG3667 at up to 6 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: PlacebosSingle doses of placebo |
| GLPG3667 MAD | Experimental | Drug: GLPG3667 oral suspensionMultiple doses of GLPG3667 at up to 3 dose levels in ascending order, daily for 13 days |
| Placebo MAD | Placebo comparator | Drug: PlacebosMultiple doses of placebo |
| GLPG3667 FE fasted | Experimental | Drug: GLPG3667 oral suspensionSingle dose of GLPG3667 in fasted state |
| GLPG3667 FE fed | Experimental | Drug: GLPG3667 oral suspensionSingle dose of GLPG3667 in fed state |
| GLPG3667 oral suspension rBA-FE fed | Experimental | Drug: GLPG3667 oral suspensionSingle dose of GLPG3667 oral suspension in fed state |
| GLPG3667 capsules rBA-FE fasted | Experimental | Drug: GLPG3667 capsulesSingle dose of GLPG3667 capsules in fasted state |
| GLPG3667 capsules rBA-FE fed | Experimental | Drug: GLPG3667 capsulesSingle dose of GLPG3667 capsules in fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male between 18-55 years of age (extremes included), on the date of signing the informed consent form (ICF)
- A body mass index (BMI) between 18-30 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, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts must be above the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be within normal ranges. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator
Key exclusion criteria (3 listed)
- Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator
- Known contraindication or hypersensitivity to Interferon-alpha (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part)
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.
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 |
|---|---|---|
| GLPG3667 oral suspensionGLPG3667 oral suspension | Drug | GLPG3667 FE fasted, GLPG3667 FE fed, GLPG3667 MAD, GLPG3667 SAD, GLPG3667 oral suspension rBA-FE fed |
| PlacebosPlacebo oral suspension | Drug | Placebo MAD, Placebo SAD |
| GLPG3667 capsulesGLPG3667 capsules | Drug | GLPG3667 capsules rBA-FE fasted, GLPG3667 capsules rBA-FE fed |
Primary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
Time frame: From screening through study completion, an average of 5 months
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG3667 (μg/mL)
Time frame: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3667 (μg.h/mL)
Time frame: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 (h)
Time frame: Between Day 1 pre-dose and Day 16
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.
Magdalena Petkova, 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 oral suspension and GLPG3667 capsules 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 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 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?
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations (time frame: From screening through study completion, an average of 5 months). 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; AzTrials last refreshed its copy on 2 Nov 2026.