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Completed
NCT07479745
Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019
Conditions: Healthy Male Volunteers
Sex: Male
Ages: 30 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 10
Sponsor: Grünenthal GmbH
Location: Quotient Sciences Nottingham
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 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)
Source: ClinicalTrials.gov (NCT07479745). StuddyBuddy aggregates publicly available trial information.