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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Male Volunteers
• Intervention / Treatment: Drug: [14C]GRT6019

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Grünenthal Clinical Trial Information; Phone Number: +49 241 569 3223; Email: clinical-trials@grunenthal.com
• Study Contact Backup: Name: Transparency and Public Disclosure Coordinator; Email: clinical-trials@grunenthal.com

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Recruiting
    • Quotient Sciences
    • Contact: Philip Evans, MBChB, MRCS (Ed); Phone Number: +44 (0) 330 303 1000
    • Contact: Quotient Sciences Recruitment; Phone Number: +44 (0) 330 303 1000; Email: recruitment@weneedyou.co.uk
    • Principal Investigator: Philip Evans, MBChB, MRCS (Ed)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]GRT6019; Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h.	Drug: [14C]GRT6019; Single administration in a single dosing period.; Other Names: Tegacorat; GRM-01; GRT6019

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative amount of total radioactivity excreted (CumAe)	To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019	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)	To determine the mass balance recovery of total radioactivity in all excreta (urine and faeces) after a single dose of [14C]GRT6019	Day -1 (Admission), Day 1 up to Days 47-48.
Metabolite profling and structural identification	To perform metabolite profiling, structural identification, and quantification analysis from plasma, urine and faecal samples	Day -1 (Admission), Day 1 up to Days 47-48.

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2026
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HP6019-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No