A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants

The purpose of this trial is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of a single oral dose of GRT6019 in healthy male participants, including food effect. This is an open-label, single-dose, single-center Phase I trial with healthy male participants. The trial will consist of 2 cohorts with a total duration of approximately 7 weeks, including a 28-day Screening Period. The participants will receive a single dose of GRT6019 administered on Day 1 and will remain at the clinic for 7 additional days. Following the in-house stay, there will be 2 Follow-up Visits up until Day 23, with 3 clinic visits scheduled

NCT Number	NCT07317063
Lead Sponsor	Grünenthal GmbH
Conditions	Duchenne Muscular Dystrophy (DMD)
Enrollment	18 participants
Start Date	2025-11-21
Primary Completion	2026-01-06 (estimated)
Study Completion	2026-01-06 (estimated)
Updated on ClinicalTrials.gov	2026-02-13