HealthyPhase 1NCT04653467
A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects
A Phase 1 study testing GLPG4399 oral suspension and GLPG4399 capsules in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Canada.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. Read more about this study
- Who is it for?
- Ages 18 to 54 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG4399 oral suspension and GLPG4399 capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 6 Nov 2020to 10 Jan 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 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. Total 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.
- Subject must be able and willing to comply with restrictions on prior and concomitant medication
- Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
- Able and willing to comply with the clinical study protocol (CSP) requirements and to sign and date the ICF as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
Who cannot join
- Subject has a history of any drug allergies.
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- 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 IP.
- Subject testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real-time polymerase chain reaction (RT-PCR) or subjects who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection as detected at screening and/or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc.) will also be excluded. In addition, any other locally applicable standard diagnostic criteria may also apply to diagnose SARS-CoV-2 infection.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IP.
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- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate (eGFR) <=90 mL/min/1.73 m2, using the modification of diet in renal disease (MDRD) formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- History of malignancy within the past 5 years prior to screening with the exception of excised and curatively treated non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin which is considered cured with minimal risk of recurrence.
- Vital sign abnormalities (systolic blood pressure <90 or >140 mmHg, diastolic blood pressure <60 or >90 mmHg, or heart rate <60 or >100 bpm) at screening.
- History or presence of clinically significant abnormalities detected on 12-lead ECG of either rhythm or conduction e.g. known long QT syndrome or a QT interval corrected for heart rate using Fridericia's formula: QTcF = QT/RR1/3 (QTcF) >450 ms detected on the 12-lead ECG. A first-degree atrioventricular block will not be considered as a significant abnormality.
- Personal or family history of long QT syndrome or unexplained sudden cardiac death in a first-degree relative.
- Male subjects with female partners of child bearing potential not willing to comply with the contraceptive methods
- Significant blood loss (including blood donation [>450 mL]), or transfusion of any blood product within 12 weeks prior to (first) dosing.
- Treatment with any drug known to have a potential for major organ toxicity in the last 3 months before first dosing of the IP.
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, dietary supplements, nutraceuticals, vitamins and/or herbal supplements) 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 of IP.
- Active drug abuse or alcohol abuse (alcohol abuse defined as regular weekly intake of more than 14 units1) within 2 years prior to first IP administration.
- Active smoker and/or has used e-cigarettes, nicotine, or nicotine-containing products within the past 6 months before the first IP administration.
- Regular consumption of a large quantity of caffeinated coffee, tea (>6 cups per day) or equivalent.
- Concurrent participation or participation in a drug, drug/device or biologic investigational research study within 12 weeks or 5 half-lives of the IP, whichever is longer, prior to first dosing.
- Investigator or other study staff or relative thereof who is directly involved in the conduct of the study.
- Any condition or circumstances that in the opinion of the investigator may make a subject unlikely or unable to complete the study or comply with study procedures and requirements.
Trial locations and contacts
1 site in 1 country.
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 GLPG4399 in Adult, Healthy, Male Subjects
The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).
- Conditions
- Healthy
- Being tested
- GLPG4399 oral suspension, GLPG4399 capsules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG4399 oral suspensionDrug
GLPG4399 for oral administration
GLPG4399 capsulesDrug
GLPG4399 for oral administration
PlaceboDrug
Placebo oral suspension
| Study group | Role | What they receive |
|---|---|---|
| GLPG4399 SAD | Experimental | Single doses of GLPG4399 at up to 6 dose levels in ascending order Receives: Drug: GLPG4399 oral suspension |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebo |
| GLPG4399 MAD | Experimental | Multiple ascending doses of GLPG4399 Receives: Drug: GLPG4399 oral suspension |
| Placebo MAD | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo |
| GLPG4399 FE-rBA | Experimental | Single dose of GLPG4399 in fed and fasted state Receives: Drug: GLPG4399 oral suspension; Drug: GLPG4399 capsules |
| GLPG4399 FE | Experimental | Single dose of GLPG4399 in fed and fasted state Receives: Drug: GLPG4399 oral suspension |
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 (SAEs), and TEAEs leading to treatment discontinuations.
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.
Measured: From screening through study completion, an average of 6 months
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of GLPG4399
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG4399, in adult, healthy, male subjects.
Measured: Between Day 1 pre-dose and Day 33
Area under curve (AUC) of GLPG4399
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG4399, in adult, healthy, male subjects.
Measured: Between Day 1 pre-dose and Day 33
Terminal elimination half-life (t1/2) of GLPG4399
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG4399, in adult, healthy, male subjects.
Measured: Between Day 1 pre-dose and Day 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start6 Nov 2020
- Primary completion10 Jan 2022
- Study completion10 Jan 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
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: a randomized, double-blind, single ascending dose (SAD), Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation and Part 3 and 4: an open-label, randomized, crossover rBA and food-effect (FE) part.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 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
- NCT04653467
- Sponsor's protocol ID
- GLPG4399-CL-101
- Status last verified
- Jan 2022
- First submitted
- 27 Nov 2020
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. 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 GLPG4399 in Adult, Healthy, Male Subjects
- ClinicalTrials.gov ID
- NCT04653467
- Acronym / sponsor ID
- GLPG4399-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 4 Dec 2020 (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, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1: a randomized, double-blind, single ascending dose (SAD), Part 2: a randomized, double-blind, multiple ascending dose (MAD) escalation and Part 3 and 4: an open-label, randomized, crossover rBA and food-effect (FE) part.
| Arm | Type | Receives |
|---|---|---|
| GLPG4399 SAD | Experimental | Drug: GLPG4399 oral suspensionSingle doses of GLPG4399 at up to 6 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: PlaceboSingle doses of placebo |
| GLPG4399 MAD | Experimental | Drug: GLPG4399 oral suspensionMultiple ascending doses of GLPG4399 |
| Placebo MAD | Placebo comparator | Drug: PlaceboMultiple doses of placebo |
| GLPG4399 FE-rBA | Experimental | Drug: GLPG4399 oral suspension, Drug: GLPG4399 capsulesSingle dose of GLPG4399 in fed and fasted state |
| GLPG4399 FE | Experimental | Drug: GLPG4399 oral suspensionSingle dose of GLPG4399 in fed and fasted state |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male between 18 and 55 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. Total 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.
- Subject must be able and willing to comply with restrictions on prior and concomitant medication
- Negative screen for drugs (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
Key exclusion criteria (21 listed)
- Subject has a history of any drug allergies.
- Known hypersensitivity to investigational product (IP) ingredients or history of a significant allergic reaction to IP ingredients as determined by the investigator.
- 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 IP.
- Subject testing positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as detected by real-time polymerase chain reaction (RT-PCR) or subjects who have been in contact with SARS-CoV-2 infected individuals in the 2 weeks prior to first dosing of IP. Subjects presenting any signs or symptoms of SARS-CoV-2 infection as detected at screening and/or baseline following careful physical examination (e.g. cough, fever, headaches, fatigue, dyspnea, myalgia, anosmia, dysgeusia, anorexia, sore throat, etc.) will also be excluded. In addition, any other locally applicable standard diagnostic criteria may also apply to diagnose SARS-CoV-2 infection.
- History of or a current immunosuppressive condition (e.g. human immunodeficiency virus (HIV) infection).
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 |
|---|---|---|
| GLPG4399 oral suspensionGLPG4399 for oral administration | Drug | GLPG4399 FE, GLPG4399 FE-rBA, GLPG4399 MAD, GLPG4399 SAD |
| GLPG4399 capsulesGLPG4399 for oral administration | Drug | GLPG4399 FE-rBA |
| PlaceboPlacebo oral suspension | Drug | Placebo MAD, Placebo SAD |
Primary outcome
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Time frame: From screening through study completion, an average of 6 months
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG4399 in adult, healthy, male subjects.
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG4399
Time frame: Between Day 1 pre-dose and Day 33
Area under curve (AUC) of GLPG4399
Time frame: Between Day 1 pre-dose and Day 33
Terminal elimination half-life (t1/2) of GLPG4399
Time frame: Between Day 1 pre-dose and Day 33
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 1 Feb 2022.
- 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 GLPG4399 oral suspension and GLPG4399 capsules 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 6 inclusion and 21 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 1 Feb 2022. 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. 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 (SAEs), and TEAEs leading to treatment discontinuations. (time frame: From screening through study completion, an average of 6 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 1 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.