NCT07479745

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	[14C]GRT6019	Single administration in a single dosing period.

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-06-06
• Completion: 2026-06-06
• First posted: 2026-03-18
• Last updated: 2026-04-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study