Healthy Male VolunteersPhase 1NCT07479745
Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019
A Phase 1 study testing [14C]GRT6019 in people with Healthy Male Volunteers, run by Grünenthal GmbH at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019 Read more about this study
- Who is it for?
- Ages 30 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Volunteers
- What is being tested?
- [14C]GRT6019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2026to 18 Jun 2026
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
- Aged 30 to 65 years inclusive at the time of signing informed consent
Who cannot join
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder
- History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants
The main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019
Read the detailed description
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
- Conditions
- Healthy Male Volunteers
- Being tested
- [14C]GRT6019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]GRT6019Drug
Also called Tegacorat, GRM-01, GRT6019
Single administration in a single dosing period.
| Study group | Role | What they receive |
|---|---|---|
| [14C]GRT6019 | Experimental | Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h. Receives: Drug: [14C]GRT6019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative amount of total radioactivity excreted (CumAe)
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019
Measured: Day -1 (Admission), Day 1 up to Days 47-48.
Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae)
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019
Measured: Day -1 (Admission), Day 1 up to Days 47-48.
Metabolite profling and structural identification
To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples
Measured: Day -1 (Admission), Day 1 up to Days 47-48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start25 Mar 2026
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male VolunteersStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479745
- Sponsor's protocol ID
- HP6019-04
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07479745
- Acronym / sponsor ID
- HP6019-04
- Conditions
- Healthy Male Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 18 Jun 2026 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 18 Mar 2026 (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 main purpose of this study is to determine the mass balance recovery and the metabolite profile of a single dose of carbon-14 ([14C]) GRT6019
Detailed description
This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]GRT6019 | Experimental | Drug: [14C]GRT6019Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers
- Aged 30 to 65 years inclusive at the time of signing informed consent
Key exclusion criteria (5 listed)
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
- Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
- History of clinically significant cardiovascular, renal, hepatic, respiratory, particularly gastrointestinal (GI) disease, especially peptic ulceration, clinically significant GI bleeding, ulcerative colitis, Crohn's disease or irritable bowel syndrome, neurological or psychiatric disorder, or clinically significant dermatological disorder
- History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)
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 |
|---|---|---|
| [14C]GRT6019Also: Tegacorat, GRM-01, GRT6019Single administration in a single dosing period. | Drug | [14C]GRT6019 |
Primary outcome
Cumulative amount of total radioactivity excreted (CumAe)
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019
Cumulative amount of total radioactivity excreted expressed as a percentage of the radioactive dose administered (Cum%Ae)
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019
Metabolite profling and structural identification
Time frame: Day -1 (Admission), Day 1 up to Days 47-48.
To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples
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 12 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 [14C]GRT6019 in people with Healthy Male Volunteers, run by Grünenthal GmbH 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 2 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 12 Aug 2026. 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?
Cumulative amount of total radioactivity excreted (CumAe) (time frame: Day -1 (Admission), Day 1 up to Days 47-48.). 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 12 Aug 2026.