HealthyPhase 1NCT05335447
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3667
A Phase 1 study testing GLPG3667 capsule, [14C]-GLPG3667 solution for infusion and [14C]-GLPG3667 capsule in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
Trial summary
This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability. Read more about this study
- Who is it for?
- Ages 30 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GLPG3667 capsule, [14C]-GLPG3667 solution for infusion and [14C]-GLPG3667 capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Apr 2022to 3 Jun 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 30 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Has a regular daily defecation pattern (i.e. 1 to 3 times per day).
- 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. 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 within normal range. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal 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 GLPG3667 ingredients or history of a significant allergic reaction to GLPG3667 ingredients as determined by the investigator
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, COVID-19 vaccines, 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.
- Subject has participated in a [14C]-radiolabeled study within the past 12 months.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.
- This list only contains the key exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study in Healthy Male Subjects to Investigate the Metabolism and Excretion Pathways of GLPG3667 Following a Single Oral Dose of [14C]-GLPG3667 and to Determine the Absolute Bioavailability Relative to an Intravenous [14C]-GLPG3667 Microtracer
This is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.
- Conditions
- Healthy
- Being tested
- GLPG3667 capsule, [14C]-GLPG3667 solution for infusion, [14C]-GLPG3667 capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3667 capsuleDrug
On Day 1, participants will receive a single oral dose of GLPG3667
[14C]-GLPG3667 solution for infusionDrug
On Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion
[14C]-GLPG3667 capsuleDrug
On Day 1, participants will receive a single oral dose of [14C]-GLPG3667
| Study group | Role | What they receive |
|---|---|---|
| Period 1 - Absolute Bioavailability | Experimental | Not described Receives: Drug: GLPG3667 capsule; Drug: [14C]-GLPG3667 solution for infusion |
| Period 2 - Mass Balance | Experimental | Not described Receives: Drug: [14C]-GLPG3667 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)
Measured: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)
Measured: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)
Measured: From Day 1 until at least Day 8 in Period 2
Percentage of TRA in plasma and excreta for metabolites of interest
Measured: From Day 1 until at least Day 8 in Period 2
Absolute oral bioavailability (F[percentage]) of GLPG3667
Measured: From Day 1 until Day 4 in Period 1
Secondary outcomes (1)
Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations.
Measured: From Day 1 through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start19 Apr 2022
- Primary completion3 Jun 2022
- Study completion3 Jun 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335447
- Sponsor's protocol ID
- GLPG3667-CL-107
- Other IDs
- 2021-006730-39
- Status last verified
- Jun 2022
- First submitted
- 13 Apr 2022
- Last updated
- 30 Jun 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 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study in Healthy Male Subjects to Investigate the Metabolism and Excretion Pathways of GLPG3667 Following a Single Oral Dose of [14C]-GLPG3667 and to Determine the Absolute Bioavailability Relative to an Intravenous [14C]-GLPG3667 Microtracer
- ClinicalTrials.gov ID
- NCT05335447
- Acronym / sponsor ID
- GLPG3667-CL-107
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 19 Apr 2022 (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 is a study in healthy male volunteers to assess how a new test medicine is taken up and broken down by the body as well as its safety and tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Period 1 - Absolute Bioavailability | Experimental | Drug: GLPG3667 capsule, Drug: [14C]-GLPG3667 solution for infusion |
| Period 2 - Mass Balance | Experimental | Drug: [14C]-GLPG3667 capsule |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male between 30 and 64 years of age (extremes included), on the date of signing the informed consent form (ICF).
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- Has a regular daily defecation pattern (i.e. 1 to 3 times per day).
- 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. 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 within normal range. Other clinical laboratory safety test results must be within the normal ranges or test results that are outside the normal 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 (5 listed)
- Known hypersensitivity to GLPG3667 ingredients or history of a significant allergic reaction to GLPG3667 ingredients as determined by the investigator
- Treatment with any medication (including over-the-counter (OTC) and/or prescription medication, COVID-19 vaccines, 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.
- Subject has participated in a [14C]-radiolabeled study within the past 12 months.
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. Occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 (UK, 2017), cannot participate in the study.
- 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 |
|---|---|---|
| GLPG3667 capsuleOn Day 1, participants will receive a single oral dose of GLPG3667 | Drug | Period 1 - Absolute Bioavailability |
| [14C]-GLPG3667 solution for infusionOn Day 1, participants will receive a single microtracer microdose of [14C]-GLPG3667 as an intravenous infusion | Drug | Period 1 - Absolute Bioavailability |
| [14C]-GLPG3667 capsuleOn Day 1, participants will receive a single oral dose of [14C]-GLPG3667 | Drug | Period 2 - Mass Balance |
Primary outcome
Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%)
Time frame: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in feces expressed as a percentage of the administered dose (Af%)
Time frame: From Day 1 until at least Day 8 in Period 2
Recovery of TRA excreted in urine and feces expressed as a percentage of the administered dose (At%)
Time frame: From Day 1 until at least Day 8 in Period 2
Percentage of TRA in plasma and excreta for metabolites of interest
Time frame: From Day 1 until at least Day 8 in Period 2
Absolute oral bioavailability (F[percentage]) of GLPG3667
Time frame: From Day 1 until Day 4 in Period 1
1 secondary 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 Day 1 through study completion, an average of 2 months
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 30 Jun 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.
Galapagos Study Director, 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 GLPG3667 capsule, [14C]-GLPG3667 solution for infusion and [14C]-GLPG3667 capsule in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
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 5 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 30 Jun 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 United Kingdom. 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. 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?
Recovery of total radioactivity (TRA) excreted in urine expressed as a percentage of the administered dose (Ae%) (time frame: From Day 1 until at least Day 8 in Period 2). The study lists 5 primary outcomes in all. 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 30 Jun 2022.