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

NCT07347548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

DRUG

GRT6019

Multiple dose (MD)

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347548 on ClinicalTrials.gov