HealthyPhase 1NCT04976270
A Study to Evaluate How Well Single and Multiple Doses of GLPG3667 Are Tolerated in Healthy, Adult Subjects
A Phase 1 study testing GLPG3667 in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in Belgium.
Trial summary
This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects. 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?
- GLPG3667
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jul 2021to 14 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 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), and alanine aminotransferase (ALT) must be below the upper limit of normal. 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 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 has resolved at least 3 months prior to first dosing of the IP.
- This list only contains the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG3667 in Adult, Healthy Male Subjects
This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (part 2) in healthy male subjects.
- Conditions
- Healthy
- Being tested
- GLPG3667, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3667Drug
GLPG3667 capsules
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| GLPG3667 SD | Experimental | Participants will receive a single dose of GLPG3667 Receives: Drug: GLPG3667 |
| Placebo SD | Placebo comparator | Participants will receive a single dose of matching placebo Receives: Drug: Placebo |
| GLPG3667 MD | Experimental | Participants will receive repeated doses of GLPG3667 for 13 days. Receives: Drug: GLPG3667 |
| Placebo MD | Placebo comparator | Participants will receive repeated doses of matching placebo for 13 days. Receives: Drug: Placebo |
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 oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
Measured: From screening through study completion, an average of 3 months
Secondary outcomes (6)
Maximum observed plasma concentration (Cmax) of GLPG3667 - SD
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
Measured: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3667 - MD
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
Measured: Between Day 1 pre-dose and Day 16
Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
Measured: Between Day 1 pre-dose and Day 4
Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
Measured: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 - SD
To evaluate the PK of single and multiple oral doses of GLPG3667 in adult, healthy male subjects.
Measured: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3667 - MD
To evaluate the PK of single and multiple oral doses of GLPG3667 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 posted26 Jul 2021
- Study start20 Jul 2021
- Primary completion14 Jan 2022
- Study completion14 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Natalia Rueda-Rincon, MD, PhD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976270
- Sponsor's protocol ID
- GLPG3667-CL-118
- Other IDs
- 2021-002488-23
- Status last verified
- Feb 2022
- First submitted
- 19 Jul 2021
- Last updated
- 14 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 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of GLPG3667 in Adult, Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04976270
- Acronym / sponsor ID
- GLPG3667-CL-118
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 14 Jan 2022 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 26 Jul 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.
This study is a phase I, randomized, double-blind, placebo-controlled, single-center, to evaluate the safety, tolerability, and pharmacokinetics (PK) of GLPG3667 after an oral single dose (SD) of GLPG3667 (part 1) and after oral multiple doses (MD) for 13 days of GLPG3667 (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 |
|---|---|---|
| GLPG3667 SD | Experimental | Drug: GLPG3667Participants will receive a single dose of GLPG3667 |
| Placebo SD | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of matching placebo |
| GLPG3667 MD | Experimental | Drug: GLPG3667Participants will receive repeated doses of GLPG3667 for 13 days. |
| Placebo MD | Placebo comparator | Drug: PlaceboParticipants will receive repeated doses of matching placebo for 13 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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), and alanine aminotransferase (ALT) must be below the upper limit of normal. 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 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 has resolved at least 3 months prior to first dosing of the IP.
- 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 |
|---|---|---|
| GLPG3667GLPG3667 capsules | Drug | GLPG3667 MD, GLPG3667 SD |
| PlaceboMatching placebo capsules | Drug | Placebo MD, Placebo SD |
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 3 months
To evaluate the safety and tolerability of single and multiple oral doses of GLPG3667, in adult, healthy, male subjects compared with placebo
6 secondary outcomes
Maximum observed plasma concentration (Cmax) of GLPG3667 - SD
Time frame: Between Day 1 pre-dose and Day 4
Maximum observed plasma concentration (Cmax) of GLPG3667 - MD
Time frame: Between Day 1 pre-dose and Day 16
Area under the plasma concentration-time curve (AUC) of GLPG3667 - SD
Time frame: Between Day 1 pre-dose and Day 4
Area under the plasma concentration-time curve (AUC) of GLPG3667 - MD
Time frame: Between Day 1 pre-dose and Day 16
Terminal elimination half-life (t1/2) of GLPG3667 - SD
Time frame: Between Day 1 pre-dose and Day 4
Terminal elimination half-life (t1/2) of GLPG3667 - MD
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 14 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.
Natalia Rueda-Rincon, MD, PhD 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 GLPG3667 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 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: finished, as of the sponsor's last update on 14 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 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 3 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 14 Feb 2022.