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

NCT07479745 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HP6019-04
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

[14C]GRT6019

EXPERIMENTAL

Participants will be dosed on the morning of Day 1 following an overnight fast of a minimum of 8 h.

Drug: [14C]GRT6019

Interventions

[14C]GRT6019 DRUG

Single administration in a single dosing period.

Also known as: Tegacorat, GRM-01, GRT6019

[14C]GRT6019

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers
• Aged 30 to 65 years inclusive at the time of signing informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

RECRUITING

Central Study Contacts

Grünenthal Clinical Trial Information

CONTACT

+49 241 569 3223; clinical-trials@grunenthal.com

Transparency and Public Disclosure Coordinator

CONTACT

clinical-trials@grunenthal.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)