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

Completed · Phase 1

Conditions studied: Duchenne Muscular Dystrophy (DMD)

In brief

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

Key facts

Study ID
NCT07317063
Run by
Grünenthal GmbH
People needed
18
Starts
2025-11-21
Expected to finish
2026-01-06
Last updated by the study team
2026-02-13

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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