HealthyPhase 1NCT04907149
Evaluation of Mass Balance and Absolute Bioavailability of GLPG3970
A Phase 1 study testing GLPG3970 film-coated tablet, [14C]GLPG3970 solution for infusion and [14]GLPG3970 oral solution in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
Trial summary
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution. 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?
- GLPG3970 film-coated tablet, [14C]GLPG3970 solution for infusion and [14]GLPG3970 oral solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2021to 12 Jul 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 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.
- Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).
- This list only contains the key inclusion criteria.
Who cannot join
- Participant 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 mSv in the last 12 month 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: A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.
- Conditions
- Healthy
- Being tested
- GLPG3970 film-coated tablet, [14C]GLPG3970 solution for infusion, [14]GLPG3970 oral solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG3970 film-coated tabletDrug
Participants will receive a single oral dose of GLPG3970.
[14C]GLPG3970 solution for infusionDrug
Participants will receive an i.v. microtracer microdose.
[14]GLPG3970 oral solutionDrug
Participants will receive a single oral dose [14C]GLPG3970.
| Study group | Role | What they receive |
|---|---|---|
| Absolute Bioavailability - Period 1 | Experimental | Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1. Receives: Drug: GLPG3970 film-coated tablet; Drug: [14C]GLPG3970 solution for infusion |
| Mass Balance - Period 2 | Experimental | Participants will receive [14C]GLPG397 under fasted conditions on Day 1. Receives: Drug: [14]GLPG3970 oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute oral bioavailability (F [%]) of GLPG3970
Measured: From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
Measured: From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
Measured: From Day 1 pre-dose until Day 8 in Period 2
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 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start7 Jun 2021
- Primary completion12 Jul 2021
- Study completion12 Jul 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekaterina Tankisheva, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907149
- Sponsor's protocol ID
- GLPG3970-CL-107
- Other IDs
- 2021-000711-23
- Status last verified
- Jul 2021
- First submitted
- 26 May 2021
- Last updated
- 23 Jul 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 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Investigate the Pharmacokinetics and Metabolism of GLPG3970 in Healthy Male Subjects Following a Single Oral Dose of GLPG3970 Relative to an Intravenous [14C]GLPG3970 Microtracer and Single Oral [14C]GLPG3970 Administration
- ClinicalTrials.gov ID
- NCT04907149
- Acronym / sponsor ID
- GLPG3970-CL-107
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Lakefront Biotherapeutics NVIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 12 Jul 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 28 May 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.
A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a tablet and an oral solution.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absolute Bioavailability - Period 1 | Experimental | Drug: GLPG3970 film-coated tablet, Drug: [14C]GLPG3970 solution for infusionParticipants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1. |
| Mass Balance - Period 2 | Experimental | Drug: [14]GLPG3970 oral solutionParticipants will receive [14C]GLPG397 under fasted conditions on Day 1. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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.
- Having a regular (at least) daily defecation pattern (i.e. 1 to 3 times per day).
- This list only contains the key inclusion criteria.
Key exclusion criteria (3 listed)
- Participant 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 mSv in the last 12 month 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 |
|---|---|---|
| GLPG3970 film-coated tabletParticipants will receive a single oral dose of GLPG3970. | Drug | Absolute Bioavailability - Period 1 |
| [14C]GLPG3970 solution for infusionParticipants will receive an i.v. microtracer microdose. | Drug | Absolute Bioavailability - Period 1 |
| [14]GLPG3970 oral solutionParticipants will receive a single oral dose [14C]GLPG3970. | Drug | Mass Balance - Period 2 |
Primary outcome
Absolute oral bioavailability (F [%]) of GLPG3970
Time frame: From Day 1 pre-dose until Day 4 in Period 1
Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%).
Time frame: From Day 1 pre-dose until Day 8 in Period 2
Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%).
Time frame: From Day 1 pre-dose until Day 8 in Period 2
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 1 month
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 23 Jul 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.
Ekaterina Tankisheva 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 GLPG3970 film-coated tablet, [14C]GLPG3970 solution for infusion and [14]GLPG3970 oral solution 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 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 23 Jul 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 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?
Absolute oral bioavailability (F [%]) of GLPG3970 (time frame: From Day 1 pre-dose until Day 4 in Period 1). The study lists 3 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 23 Jul 2021.