HealthyPhase 1NCT04575818
A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059
A Phase 1 study testing GLPG4059 oral suspension and GLPG4059 tablet in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). 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?
- GLPG4059 oral suspension and GLPG4059 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Sep 2020to 8 Apr 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 54 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 18-54 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. ECG and vital signs parameters must be within the normal ranges. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal (ULN). Fasting plasma glucose must be <6.99 mmol/L, fasting defined as no caloric intake for at least 8 hours and hemoglobin A1c (HbA1c) <6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is national glycohemoglobin standardization program (NGSP) certified and standardized to the diabetes control and complications trial (DCCT) assay. 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.
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.
- 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.
- This list only contains the key exclusion criteria.
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 Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects
The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
- Conditions
- Healthy
- Being tested
- GLPG4059 oral suspension, Placebo, GLPG4059 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG4059 oral suspensionDrug
GLPG4059 for oral administration
PlaceboDrug
Placebo oral suspension
GLPG4059 tabletDrug
GLPG4059 for oral administration
| Study group | Role | What they receive |
|---|---|---|
| GLPG4059 SAD | Experimental | Single doses of GLPG4059 at up to 6 dose levels in ascending order Receives: Drug: GLPG4059 oral suspension |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebo |
| GLPG4059 rBA/FE oral suspension fasted | Experimental | Single dose of GLPG4059 in fasted state Receives: Drug: GLPG4059 oral suspension |
| GLPG4059 rBA/FE tablet fed | Experimental | Single dose of GLPG4059 in fed state Receives: Drug: GLPG4059 tablet |
| GLPG4059 rBA/FE tablet fasted | Experimental | Single dose of GLPG4059 in fasted state Receives: Drug: GLPG4059 tablet |
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 ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.
Measured: From screening through study completion, an average of 7 months
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of GLPG4059
To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG4059, in adult, healthy, male subjects.
Measured: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG4059
To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG4059
To evaluate the PK of single ascending oral doses of GLPG4059, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start16 Sep 2020
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
Why it stopped: Development of compound has been stopped
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 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT04575818
- Sponsor's protocol ID
- GLPG4059-CL-101
- Other IDs
- 2020-000036-22
- Status last verified
- May 2021
- First submitted
- 29 Sep 2020
- Last updated
- 11 May 2021
- 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 11 May 2021. 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 Ascending Oral Doses of GLPG4059 in Adult, Healthy, Male Subjects
- ClinicalTrials.gov ID
- NCT04575818
- Acronym / sponsor ID
- GLPG4059-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development of compound has been stopped
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 5 Oct 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 and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Part 1 (SAD) is randomized, double-blind, placebo-controlled; Part 2 (FE and rBA) is randomized, open-label.
| Arm | Type | Receives |
|---|---|---|
| GLPG4059 SAD | Experimental | Drug: GLPG4059 oral suspensionSingle doses of GLPG4059 at up to 6 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: PlaceboSingle doses of placebo |
| GLPG4059 rBA/FE oral suspension fasted | Experimental | Drug: GLPG4059 oral suspensionSingle dose of GLPG4059 in fasted state |
| GLPG4059 rBA/FE tablet fed | Experimental | Drug: GLPG4059 tabletSingle dose of GLPG4059 in fed state |
| GLPG4059 rBA/FE tablet fasted | Experimental | Drug: GLPG4059 tabletSingle dose of GLPG4059 in fasted state |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male between 18-54 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 ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. ECG and vital signs parameters must be within the normal ranges. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal (ULN). Fasting plasma glucose must be <6.99 mmol/L, fasting defined as no caloric intake for at least 8 hours and hemoglobin A1c (HbA1c) <6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is national glycohemoglobin standardization program (NGSP) certified and standardized to the diabetes control and complications trial (DCCT) assay. 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.
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.
- 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.
- 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 |
|---|---|---|
| GLPG4059 oral suspensionGLPG4059 for oral administration | Drug | GLPG4059 SAD, GLPG4059 rBA/FE oral suspension fasted |
| PlaceboPlacebo oral suspension | Drug | Placebo SAD |
| GLPG4059 tabletGLPG4059 for oral administration | Drug | GLPG4059 rBA/FE tablet fasted, GLPG4059 rBA/FE tablet 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 7 months
To evaluate the safety and tolerability of single ascending oral doses of GLPG4059, in adult, healthy, male subjects compared with placebo.
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG4059
Time frame: Between Day 1 pre-dose and Day 4
Area under curve (AUC) of GLPG4059
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG4059
Time frame: Between Day 1 pre-dose and Day 4
Results and safety
The study was stopped early (reason given: Development of compound has been stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- 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 GLPG4059 oral suspension and GLPG4059 tablet in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Netherlands.
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: stopped early, as of the sponsor's last update on 11 May 2021. 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 Netherlands. 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 was stopped early (reason given: Development of compound has been stopped). Results are not available in the source record.
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 7 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 11 May 2021.