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Study finishedPhase1

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

Sponsor: Grünenthal GmbH

NCT ID: NCT07479745

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
[14C]GRT6019 (drug)
How long the study runs
Study runs about 3 months (dates as stated)
About the drug or intervention
[14C]GRT6019 — drug: Single administration in a single dosing period.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
30 Years to 65 Years
Who
Male
Number of participants
10
Started
2026-03-25
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy male volunteers
  • • Phase1 - 10 participants
  • • 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 take part?

  • • Ages 30 Years to 65 Years
  • • Diagnosed with healthy male volunteers
  • • Male only

Where?

  • • Nottingham - Quotient Sciences

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

This is an open-label, non-randomized, single-dose study in healthy male participants. It is planned to enroll a total of ten participants to ensure data in a minimum of six participants. The estimated time for duration of study will be up to 11 weeks.

Healthy Male Volunteers

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 30 Years - 65 Years
  • Who can join: Male only

What the study is looking for

  • ✓Healthy volunteers
  • ✓Aged 30 to 65 years inclusive at the time of signing agreement to take part

Who cannot take part

  • ✗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...
  • ✗Presence or history of diseases or conditions known to interfere with the absorption, distribution, metabolism or...
  • ✗History of GI surgery (with the exception of appendectomy or hernia repair unless it was performed within the...
See the full 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 Is This Study? (1 UK site)

Quotient Sciences

Nottingham NG11 6JS, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08