Mass balance and metabolite mapping of radiolabeled GRT6019 in healthy men

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

This study will test how a single carbon-14 labeled dose of GRT6019 is absorbed, distributed, metabolized and eliminated in healthy men aged 30–65.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 30 Years to 65 Years
• Sex: Male
• Sponsor: Grünenthal GmbH (Industry-sponsored)
• Locations: 1 site (Nottingham)
• Trial ID: NCT07479745 on ClinicalTrials.gov

What this trial studies

This open-label, non-randomized, single-dose study gives one radiolabeled dose of [14C]GRT6019 to healthy male volunteers and tracks the drug and its breakdown products over time. Researchers will collect blood, urine and feces samples to measure mass balance recovery and identify metabolites. The plan is to enroll ten participants to ensure complete data in at least six people, with follow-up sampling and safety checks over a period of up to 11 weeks. Results will define the compound’s metabolic pathways and the proportion of dose recovered unchanged or as metabolites.

Who should consider this trial

Good fit: Ideal candidates are healthy men aged 30–65 without significant medical conditions, no interfering GI or metabolic disorders, and able to comply with serial sample collection and follow-up.

Not a fit: People outside the age range, women, or those with significant cardiovascular, renal, hepatic, gastrointestinal, neurological, psychiatric, or metabolic conditions (or relevant prior GI surgery) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study will clarify how GRT6019 is processed by the body, information that can improve safety and dosing decisions in later patient studies.

How similar studies have performed: Mass-balance studies using radiolabeled compounds are a standard, well-established method and have successfully defined metabolic pathways for many investigational drugs.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active
3. Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs
4. 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
5. History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the previous 12 months)

Where this trial is running

Nottingham

• Quotient Sciences — Nottingham, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Grünenthal Clinical Trial Information

Conditions Healthy Male Volunteers