HealthyPhase 1NCT04106297
A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3970
A Phase 1 study testing GLPG3970 oral solution and GLPG3970 capsule in people with Healthy and Psoriasis, run by Lakefront Biotherapeutics NV at 3 sites in 3 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- GLPG3970 oral solution and GLPG3970 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 10 Sep 2019to 5 Mar 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). 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.
- This list only contains the key inclusion criteria for the healthy volunteers part of the study.
- Male or female between 18-65 years of age (extremes included), on the date of signing the ICF.
- Diagnosed with plaque psoriasis ≥6 months.
Show all 9Show fewer
- Screening Psoriasis Area and Severity Index (PASI) ≥12 (moderate to severe) and affected body surface area (BSA) ≥10%.
- A body mass index (BMI) between 18-35 kg/m2, inclusive.
- This list only contains the key inclusion criteria for Part 4 of the study.
Who cannot join
- Known hypersensitivity to the Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus 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.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
- This list only contains the key exclusion criteria for the healthy volunteers part of the study.
- Subject has evidence of skin conditions other than psoriasis (e.g., eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
- Subject is unable to discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) from signing of the ICF up to the end of the study.
- This list only contains the key inclusion criteria for Part 4 of the study.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Belgium1 site
SGS Belgium NV - Clinical Pharmacology Unit Antwerp
Antwerp, 2060
Moldova1 site
Clinical Republican Hospital Arensia Experimental Medicine
Chisinau, MD2025
About this study
Official title: A First-in-human, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GLPG3970 Single and Multiple Ascending Doses in Adult Healthy Male Subjects, and in Psoriasis Subjects When Administered Daily for 6 Weeks
The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
- Being tested
- GLPG3970 oral solution, Placebo oral solution, GLPG3970 capsule
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3970 oral solutionDrug
GLPG3970 for oral administration
Placebo oral solutionDrug
Placebo for oral administration
GLPG3970 capsuleDrug
GLPG3970 for oral administration
| Study group | Role | What they receive |
|---|---|---|
| GLPG3970 SAD | Experimental | Single doses of GLPG3970 at up to 6 dose levels in ascending order Receives: Drug: GLPG3970 oral solution |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebo oral solution |
| GLPG3970 MAD | Experimental | Multiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days Receives: Drug: GLPG3970 oral solution |
| Placebo MAD | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo oral solution |
| GLPG3970 FE-rBA | Experimental | Single dose of GLPG3970 in fed and fasted state Receives: Drug: GLPG3970 oral solution; Drug: GLPG3970 capsule |
| GLPG3970 FE | Experimental | Single dose of GLPG3970 in fed and fasted state Receives: Drug: GLPG3970 oral solution |
| GLPG3970 in psoriasis subjects | Experimental | Not described Receives: Drug: GLPG3970 oral solution |
| Placebo in psoriasis subjects | Experimental | Not described Receives: Drug: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks
Measured: From screening through study completion, an average of 20 months
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)
To evaluate the pharmacokinetics (PK) of oral SAD of GLPG3970 in adult healthy male subjects
Measured: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Measured: Between Day 1 pre-dose and Day 17
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)
To evaluate the food effect on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)
To evaluate the PK of a single oral dose of GLPG3970 administered as an oral solution versus and oral capsule in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)
To evaluate the PK of oral SAD of GLPG3970 in adult healthy male subjects
Measured: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970 in adult healthy male subjects
Measured: Between Day 1 pre-dose and Day 17
Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)
To evaluate the food effect on the PK of a single oral dose of GLPG3970 under fed conditions (high-fat high calorie) versus fasted conditions in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 3, rBA)
To evaluate the rBA of an oral solution of GLPG3970 versus an oral capsule of GLPG3970 on the PK of a single oral dose of GLPG3970 in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)
To evaluate the PK of oral SAD of GLPG3970, in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)
To evaluate the PK of oral MAD of GLPG3970, in adult, healthy, subjects
Measured: Between Day 1 pre-dose and Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start10 Sep 2019
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
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
- Parallel groups
- Model description
- Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 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
- NCT04106297
- Sponsor's protocol ID
- GLPG3970-CL-101
- Other IDs
- 2019-001803-19, 2019
- Status last verified
- Jun 2021
- First submitted
- 25 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, Pharmacokinetics and Pharmacodynamics of GLPG3970 Single and Multiple Ascending Doses in Adult Healthy Male Subjects, and in Psoriasis Subjects When Administered Daily for 6 Weeks
- ClinicalTrials.gov ID
- NCT04106297
- Acronym / sponsor ID
- GLPG3970-CL-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 27 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.
The main purpose of this study is to evaluate the safety and tolerability of GLPG3970 in healthy volunteers after single oral administrations of GLPG3970 (SAD), compared to placebo (part 1 and 1bis) and after multiple (for 14 days) oral administrations of GLPG3970 (MAD), compared to placebo (part 2). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics of GLPG3970 and the relative bioavailability (rBA) of an oral solution versus a solid formulation will be assessed (part 3 and 3bis). Part 4 of the study is to evaluate the safety and tolerability of GLPG3970 in subjects with moderate to severe psoriasis when administered daily for 6 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Part 1 and 1bis (SAD), Part 2 (MAD) and Part 4 (psoriasis subjects) are randomized, double-blind, placebo-controlled; Part 3 (FE-rBA) and Part 3bis (FE) are randomized, open-label.
| Arm | Type | Receives |
|---|---|---|
| GLPG3970 SAD | Experimental | Drug: GLPG3970 oral solutionSingle doses of GLPG3970 at up to 6 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: Placebo oral solutionSingle doses of placebo |
| GLPG3970 MAD | Experimental | Drug: GLPG3970 oral solutionMultiple doses of GLPG3970 at up to 4 dose levels in ascending order, daily for 14 days |
| Placebo MAD | Placebo comparator | Drug: Placebo oral solutionMultiple doses of placebo |
| GLPG3970 FE-rBA | Experimental | Drug: GLPG3970 oral solution, Drug: GLPG3970 capsuleSingle dose of GLPG3970 in fed and fasted state |
| GLPG3970 FE | Experimental | Drug: GLPG3970 oral solutionSingle dose of GLPG3970 in fed and fasted state |
| GLPG3970 in psoriasis subjects | Experimental | Drug: GLPG3970 oral solution |
| Placebo in psoriasis subjects | Experimental | Drug: Placebo oral solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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 must not be below the lower limit of normal range. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal range (ULN). 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.
- This list only contains the key inclusion criteria for the healthy volunteers part of the study.
- Male or female between 18-65 years of age (extremes included), on the date of signing the ICF.
Key exclusion criteria (7 listed)
- Known hypersensitivity to the Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
- Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus 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.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus [HIV] infection).
- This list only contains the key exclusion criteria for the healthy volunteers part of the study.
- Subject has evidence of skin conditions other than psoriasis (e.g., eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis.
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 |
|---|---|---|
| GLPG3970 oral solutionGLPG3970 for oral administration | Drug | GLPG3970 FE, GLPG3970 FE-rBA, GLPG3970 MAD, GLPG3970 SAD, GLPG3970 in psoriasis subjects |
| Placebo oral solutionPlacebo for oral administration | Drug | Placebo MAD, Placebo SAD, Placebo in psoriasis subjects |
| GLPG3970 capsuleGLPG3970 for oral administration | Drug | GLPG3970 FE-rBA |
Primary outcome
Number 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 20 months
To evaluate the safety and tolerability of GLPG3970 compared to placebo in adult healthy male subjects as single and multiple ascending oral doses, and in subjects with moderate to severe psoriasis when administered daily for 6 weeks
10 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 1 and 1bis)
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 2)
Time frame: Between Day 1 pre-dose and Day 17
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3 and 3bis, FE)
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3970 (Part 3, rBA)
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 1 and 1bis)
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 2)
Time frame: Between Day 1 pre-dose and Day 17
Area under curve (AUC) of GLPG3970 (Part 3 and 3bis, FE)
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG3970 (Part 3, rBA)
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 1 and 1bis)
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3970 (Part 2)
Time frame: Between Day 1 pre-dose and Day 17
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
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLPG3970 oral solution and GLPG3970 capsule in people with Healthy and Psoriasis, run by Lakefront Biotherapeutics NV at 3 sites in 3 countries.
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 9 inclusion and 7 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 3 sites in Belgium, Moldova, Ukraine. 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 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 20 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.