RecruitingPhase 1

Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019

United Kingdom10 participantsStarted 2026-03-25

Plain-language 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

Who can participate

Age range

30 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy volunteers
. Aged 30 to 65 years inclusive at the time of signing informed consent

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative amount of total radioactivity excreted (CumAe)

Timeframe: 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)

Timeframe: Day -1 (Admission), Day 1 up to Days 47-48.

Metabolite profling and structural identification

Timeframe: Day -1 (Admission), Day 1 up to Days 47-48.

Trial details

NCT IDNCT07479745

SponsorGrünenthal GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-06

Contact for this trial

Grünenthal Clinical Trial Information

+49 241 569 3223 clinical-trials@grunenthal.com

View on ClinicalTrials.gov More Healthy Male Volunteers trials

Who can participate

Age range

30 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy volunteers
. Aged 30 to 65 years inclusive at the time of signing informed consent

Exclusion criteria

. 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)

What they're measuring

Cumulative amount of total radioactivity excreted (CumAe)

Timeframe: 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)

Timeframe: Day -1 (Admission), Day 1 up to Days 47-48.

Metabolite profling and structural identification

Timeframe: Day -1 (Admission), Day 1 up to Days 47-48.