HealthyPhase 1NCT04136327
A Study in Healthy Male Volunteers to Test How the Test Medicine GLPG1972 is Taken up by the Body When Given by Mouth and Into the Vein as an Injection
A Phase 1 study testing GLPG1972 film-coated tablets, [14C]-GLPG1972 solution for infusion and [14C]-GLPG1972 oral solution in people with Healthy, run by Lakefront Biotherapeutics NV at 1 site in United Kingdom.
Trial summary
The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 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?
- GLPG1972 film-coated tablets, [14C]-GLPG1972 solution for infusion and [14C]-GLPG1972 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
- 13 Sep 2019to 21 Oct 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 30 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
- A body mass index (BMI) between 18.0-32.0 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 ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
- Having a regular daily defecation pattern (i.e. 1 to 3 times per day).
Who cannot join
- Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
- 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 investigational medicinal product (IMP) administration.
- Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
- 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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 Administration
The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.
The sponsor will also look at the safety and tolerability of the test medicine.
- Conditions
- Healthy
- Being tested
- GLPG1972 film-coated tablets, [14C]-GLPG1972 solution for infusion, [14C]-GLPG1972 oral solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLPG1972 film-coated tabletsDrug
single oral dose of GLPG1972
[14C]-GLPG1972 solution for infusionDrug
a 15-minute IV infusion [14C]-GLPG1972
[14C]-GLPG1972 oral solutionDrug
single oral dose of [14C]-GLPG1972
| Study group | Role | What they receive |
|---|---|---|
| GLPG1972 oral and [14C]-GLPG1972 IV | Experimental | GLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion Receives: Drug: GLPG1972 film-coated tablets; Drug: [14C]-GLPG1972 solution for infusion |
| [14C]-GLPG1972 oral solution | Experimental | [14C]-GLPG1972 oral solution Receives: Drug: [14C]-GLPG1972 oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total radioactivity excreted in urine and feces combined (Period 2)
To assess the mass balance, using [14C]-GLPG1972
Measured: From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 10
Cmax of GLPG1972 (Period 2)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 10
AUC of GLPG1972 (Period 2)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 10
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)
To characterize the elimination pathways and metabolite profile of GLPG1972
Measured: From Day 1 pre-dose up to Day 7
Secondary outcomes (5)
Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 4
IV Cmax of total radioactivity (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 4
IV AUC of [14C]-GLPG1972 MT (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 4
IV AUC of total radioactivity (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Measured: From Day 1 pre-dose up to Day 4
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)
To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)
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 posted23 Oct 2019
- Study start13 Sep 2019
- Primary completion21 Oct 2019
- Study completion21 Oct 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
- 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
- Angela de Haas-Amatsaleh, MD, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136327
- Sponsor's protocol ID
- GLPG1972-CL-108
- Other IDs
- 2019-001305-25, 2019
- Status last verified
- Nov 2019
- First submitted
- 21 Oct 2019
- Last updated
- 20 Nov 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-center Study to Investigate the Pharmacokinetics and Metabolism of GLPG1972 in Healthy Male Subjects Following Single Intravenous [14C]-GLPG1972 Microtracer and Single Oral [14C]-GLPG1972 Administration
- ClinicalTrials.gov ID
- NCT04136327
- Acronym / sponsor ID
- GLPG1972-CL-108
- 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
- 13 Sep 2019 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 21 Oct 2019 (actual)
- First posted
- 23 Oct 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.
The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body, what it is broken down into, and how it leaves the body.
The sponsor will also look at the safety and tolerability of the test medicine.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLPG1972 oral and [14C]-GLPG1972 IV | Experimental | Drug: GLPG1972 film-coated tablets, Drug: [14C]-GLPG1972 solution for infusionGLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion |
| [14C]-GLPG1972 oral solution | Experimental | Drug: [14C]-GLPG1972 oral solution[14C]-GLPG1972 oral solution |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF).
- A body mass index (BMI) between 18.0-32.0 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 ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator.
- Having a regular daily defecation pattern (i.e. 1 to 3 times per day).
Key exclusion criteria (5 listed)
- Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active.
- 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 investigational medicinal product (IMP) administration.
- Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration.
- 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 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
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 |
|---|---|---|
| GLPG1972 film-coated tabletssingle oral dose of GLPG1972 | Drug | GLPG1972 oral and [14C]-GLPG1972 IV |
| [14C]-GLPG1972 solution for infusiona 15-minute IV infusion [14C]-GLPG1972 | Drug | GLPG1972 oral and [14C]-GLPG1972 IV |
| [14C]-GLPG1972 oral solutionsingle oral dose of [14C]-GLPG1972 | Drug | [14C]-GLPG1972 oral solution |
Primary outcome
Change of total radioactivity excreted in urine and feces combined (Period 2)
Time frame: From Day 1 pre-dose up to Day 10
To assess the mass balance, using [14C]-GLPG1972
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)
Time frame: From Day 1 pre-dose up to Day 10
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Cmax of GLPG1972 (Period 2)
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2)
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
AUC of GLPG1972 (Period 2)
Time frame: From Day 1 pre-dose up to Day 10
To assess the PK of GLPG1972 and its main metabolites in plasma
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)
Time frame: From Day 1 pre-dose up to Day 7
To characterize the elimination pathways and metabolite profile of GLPG1972
5 secondary outcomes
Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)
Time frame: From Day 1 pre-dose up to Day 4
IV Cmax of total radioactivity (Period 1)
Time frame: From Day 1 pre-dose up to Day 4
IV AUC of [14C]-GLPG1972 MT (Period 1)
Time frame: From Day 1 pre-dose up to Day 4
IV AUC of total radioactivity (Period 1)
Time frame: From Day 1 pre-dose up to Day 4
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)
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 20 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Angela de Haas-Amatsaleh, 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 GLPG1972 film-coated tablets, [14C]-GLPG1972 solution for infusion and [14C]-GLPG1972 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 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 20 Nov 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 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?
Change of total radioactivity excreted in urine and feces combined (Period 2) (time frame: From Day 1 pre-dose up to Day 10). The study lists 6 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 20 Nov 2019.