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

Age range30 Years – 65 Years

SexMALE

See this in plain English?

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

✕. 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)

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.

NCT IDNCT07479745

SponsorGrünenthal GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-06

Grünenthal Clinical Trial Information

Who can participate

Age range30 Years – 65 Years

SexMALE

See this in plain English?

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

✕. 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.