RecruitingPhase 1NCT07479745
Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019
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
Sponsor
Grünenthal GmbH
Enrollment
10 participants
Start Date
Mar 25, 2026
Study Type
INTERVENTIONAL
Conditions
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
Eligibility
Sex: MALEMin Age: 30 YearsMax Age: 65 Years
Inclusion Criteria2
- Healthy volunteers
- Aged 30 to 65 years inclusive at the time of signing informed consent
Exclusion Criteria5
- 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)
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Interventions
DRUG[14C]GRT6019
Single administration in a single dosing period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07479745