HealthyPhase 1NCT04856358
A Study to Evaluate How Well Single and Multiple Doses of GLPG3121-modified Release Formulation Are Tolerated in Healthy, Adult Subjects
A Phase 1 study testing GLPG3121 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Germany.
Trial summary
The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast. 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?
- GLPG3121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2021to 8 Nov 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 55 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 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. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (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.
- This list only contains the key inclusion criteria.
Who cannot join
- 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.
- 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.
- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate [eGFR] <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
- This list only contains the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3121-modified Release Formulation in Adult, Healthy, Male Subjects
The aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.
The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.
- Conditions
- Healthy
- Being tested
- GLPG3121, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3121Drug
GLPG3121 modified-release tablet
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| GLPG3121 SAD | Experimental | Single doses of GLPG3121 at up to 3 dose levels in ascending order Receives: Drug: GLPG3121 |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebo |
| GLPG3121 MAD | Experimental | Multiple doses of GLPG3121 at up to 3 dose levels in ascending order Receives: Drug: GLPG3121 |
| Placebo MAD | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo |
| GLPG3121 FE fed | Experimental | Single dose of GLPG3121 in fed state Receives: Drug: GLPG3121 |
| GLPG3121 FE fasted | Experimental | Single dose of GLPG3121 in fasted state Receives: Drug: GLPG3121 |
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 GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo
Measured: From screening through study completion, an average of 8 months
Secondary outcomes (12)
Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD
To evaluate the pharmacokinetics (PK) of single ascending oral doses of GLPG3121 in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
Cmax of GLPG3121's main metabolite in SAD
To evaluate the PK of single ascending oral doses of GLPG3121's metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
Cmax of GLPG3121 in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
Cmax of GLPG3121's main metabolite in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD
To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
AUC of GLPG3121's main metabolite in SAD
To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
AUC of GLPG3121 in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121 metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
AUC of GLPG3121's main metabolite in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
Terminal elimination half-life (t1/2) of GLPG3121 in SAD
To evaluate the PK of single ascending oral doses of GLPG3121 in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
t1/2 of GLPG3121's main metabolite in SAD
To evaluate the PK of single ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 6
t1/2 of GLPG3121 in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121 in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
t1/2 of GLPG3121's main metabolite in MAD
To evaluate the PK of multiple ascending oral doses of GLPG3121's main metabolite in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start27 Apr 2021
- Primary completion8 Nov 2021
- Study completion8 Nov 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 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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
- NCT04856358
- Sponsor's protocol ID
- GLPG3121-CL-103
- Other IDs
- 2020-004174-21
- Status last verified
- Dec 2021
- First submitted
- 14 Apr 2021
- 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 Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of GLPG3121-modified Release Formulation in Adult, Healthy, Male Subjects
- ClinicalTrials.gov ID
- NCT04856358
- Acronym / sponsor ID
- GLPG3121-CL-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 23 Apr 2021 (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 aim of the study is to examine the safety and tolerability of GLPG3121-modified release formulation when given to healthy male subjects once as a single dose or multiple times over a period of 14 days in fasting condition or after a standard breakfast.
The study will evaluate how the body absorbs and breaks down GLPG3121, and how GLPG3121 and the major breakdown product of GLPG3121 are eliminated from the body. In addition, the study will investigate the effect of food (high-fat) after a single oral dose of GLPG3121 as modified release tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part 1 Single Ascending Dose (SAD) and Part 2 Multiple Ascending Dose (MAD) are randomized, double-blind, placebo-controlled; Part 3 Food-effect (FE) is randomized, open-label, crossover
| Arm | Type | Receives |
|---|---|---|
| GLPG3121 SAD | Experimental | Drug: GLPG3121Single doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: PlaceboSingle doses of placebo |
| GLPG3121 MAD | Experimental | Drug: GLPG3121Multiple doses of GLPG3121 at up to 3 dose levels in ascending order |
| Placebo MAD | Placebo comparator | Drug: PlaceboMultiple doses of placebo |
| GLPG3121 FE fed | Experimental | Drug: GLPG3121Single dose of GLPG3121 in fed state |
| GLPG3121 FE fasted | Experimental | Drug: GLPG3121Single dose of GLPG3121 in fasted state |
Who may qualify
- Ages
- 18 to 55 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 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. Total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and serum creatinine must be no greater than the upper limit of normal (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 (6 listed)
- 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.
- 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.
- Presence or sequelae of gastrointestinal, liver, kidney (estimated glomerular filtration rate [eGFR] <=90 mL/min/1.73 m2, using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
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 |
|---|---|---|
| GLPG3121GLPG3121 modified-release tablet | Drug | GLPG3121 FE fasted, GLPG3121 FE fed, GLPG3121 MAD, GLPG3121 SAD |
| PlaceboMatching placebo | Drug | Placebo MAD, Placebo SAD |
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 8 months
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121-modified-release formulation (GLPG3121-MR), in adult, healthy, male subjects compared with placebo
12 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG3121 in SAD
Time frame: Between Day 1 pre-dose and Day 6
Cmax of GLPG3121's main metabolite in SAD
Time frame: Between Day 1 pre-dose and Day 6
Cmax of GLPG3121 in MAD
Time frame: Between Day 1 pre-dose and Day 19
Cmax of GLPG3121's main metabolite in MAD
Time frame: Between Day 1 pre-dose and Day 19
Area under the plasma concentration-time curve (AUC) of GLPG3121 in SAD
Time frame: Between Day 1 pre-dose and Day 6
AUC of GLPG3121's main metabolite in SAD
Time frame: Between Day 1 pre-dose and Day 6
AUC of GLPG3121 in MAD
Time frame: Between Day 1 pre-dose and Day 19
AUC of GLPG3121's main metabolite in MAD
Time frame: Between Day 1 pre-dose and Day 19
Terminal elimination half-life (t1/2) of GLPG3121 in SAD
Time frame: Between Day 1 pre-dose and Day 6
t1/2 of GLPG3121's main metabolite in SAD
Time frame: Between Day 1 pre-dose and Day 6
t1/2 of GLPG3121 in MAD
Time frame: Between Day 1 pre-dose and Day 19
t1/2 of GLPG3121's main metabolite in MAD
Time frame: Between Day 1 pre-dose and Day 19
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 GLPG3121 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Germany.
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 6 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 Germany. 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 8 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.