NCT07347548

A Trial to Investigate the Safety and Pharmacokinetics of GRT6019 in Healthy Male Participants

An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Grünenthal GmbH · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to assess the safety, tolerability, and PK of 3 doses of GRT6019 in healthy male participants. This Phase I trial will be a multiple dose trial in healthy male participants with administration of GRT6019 in 3 cohorts. For each participant, the trial consists of a Screening Period of up to 28 days, a 4 week Treatment Period (including a 2-week clinic stay and 2 weeks in an outpatient setting), and a 5 week Follow-up Period.

Detailed description

There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.

Conditions

• Duchenne Muscular Dystrophy (DMD)

Interventions

Type	Name	Description
DRUG	GRT6019	Multiple dose (MD)

Timeline

• Start date: 2026-01-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-01-16
• Last updated: 2026-04-09

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study