HealthyPhase 1NCT03899909
A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects
A Phase 1 study testing GLPG3121 SAD and GLPG3121 MAD 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, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of… 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 SAD and GLPG3121 MAD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Mar 2019to 3 Jun 2019
- 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
- Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
- Male between 18 to 55 years of age (extremes included), on the date of signing the ICF.
- A Body Mass Index (BMI) between 18.0 to 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, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts 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 the 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 nonclinically 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-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
- Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) 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.
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, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.
This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.
- Conditions
- Healthy
- Being tested
- GLPG3121 SAD, Placebo SAD, GLPG3121 MAD, Placebo MAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3121 SADDrug
GLPG3121 oral suspension, single ascending doses
Placebo SADDrug
Placebo oral suspension
GLPG3121 MADDrug
GLPG3121 oral suspension, multiple ascending doses, daily for 13 days
Placebo MADDrug
Placebo oral suspension, daily for 13 days
| Study group | Role | What they receive |
|---|---|---|
| GLPG3121 SAD | Experimental | Single doses of GLPG3121 at up to 6 dose levels in ascending order Receives: Drug: GLPG3121 SAD |
| Placebo SAD | Placebo comparator | Single doses of placebo Receives: Drug: Placebo SAD |
| GLPG3121 MAD | Experimental | Multiple doses of GLPG3121 at up to 4 dose levels in ascending order Receives: Drug: GLPG3121 MAD |
| Placebo MAD | Placebo comparator | Multiple doses of placebo Receives: Drug: Placebo MAD |
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, in adult, healthy, male subjects compared with placebo.
Measured: From screening through study completion, an average of 6 months.
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)
To evaluate the pharmacokinetics (PK) of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3121 (μg.h/mL)
To evaluate the PK of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects
Measured: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3121 (h)
To evaluate the PK of single and multiple ascending oral doses of GLPG3121, 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 posted2 Apr 2019
- Study start29 Mar 2019
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
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
- 31 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
- NCT03899909
- Sponsor's protocol ID
- GLPG3121-CL-101
- Other IDs
- 2018-002174-40, 2018
- Status last verified
- Jul 2019
- First submitted
- 1 Apr 2019
- Last updated
- 5 Jul 2019
- 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 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Double-blind, Placebo-controlled, Single Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of GLPG3121 for 13 Days in Adult, Healthy, Male Subjects.
- ClinicalTrials.gov ID
- NCT03899909
- Acronym / sponsor ID
- GLPG3121-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 2 Apr 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, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GLPG3121 SAD | Experimental | Drug: GLPG3121 SADSingle doses of GLPG3121 at up to 6 dose levels in ascending order |
| Placebo SAD | Placebo comparator | Drug: Placebo SADSingle doses of placebo |
| GLPG3121 MAD | Experimental | Drug: GLPG3121 MADMultiple doses of GLPG3121 at up to 4 dose levels in ascending order |
| Placebo MAD | Placebo comparator | Drug: Placebo MADMultiple doses of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able and willing to comply with the protocol requirements and signing the Informed Consent Form (ICF) as approved by the Independent Ethical Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations.
- Male between 18 to 55 years of age (extremes included), on the date of signing the ICF.
- A Body Mass Index (BMI) between 18.0 to 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, (triplicate) 12-lead electrocardiogram (ECG), and fasting clinical laboratory safety tests, available at screening and prior to randomization. Hemoglobin, neutrophil, lymphocyte, and platelet counts 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 the 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 nonclinically significant in the opinion of the investigator.
Key exclusion criteria (5 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-α (IFN-α) or any component of Intron-A® (Note: this criterion is only applicable to subjects in the MAD part).
- Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first dosing of the IMP.
- Presence or sequelae of gastrointestinal, liver, kidney (creatinine clearance ≤80 mL/min using the Cockcroft-Gault formula: if calculated result is ≤80 mL/min a 24-hours urine collection to assess creatinine clearance can be done) 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.
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 |
|---|---|---|
| GLPG3121 SADGLPG3121 oral suspension, single ascending doses | Drug | GLPG3121 SAD |
| Placebo SADPlacebo oral suspension | Drug | Placebo SAD |
| GLPG3121 MADGLPG3121 oral suspension, multiple ascending doses, daily for 13 days | Drug | GLPG3121 MAD |
| Placebo MADPlacebo oral suspension, daily for 13 days | Drug | Placebo MAD |
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 6 months.
To evaluate the safety and tolerability of single and multiple ascending oral doses of GLPG3121, in adult, healthy, male subjects compared with placebo.
3 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG3121 (μg/mL)
Time frame: Between Day 1 pre-dose and Day 16
Area under curve (AUC) of GLPG3121 (μg.h/mL)
Time frame: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3121 (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 5 Jul 2019.
- 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 SAD and GLPG3121 MAD 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 4 inclusion and 5 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 5 Jul 2019. 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 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 5 Jul 2019.