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

NCT07317063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-13

No results posted yet for this study

Summary

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

Conditions

  • Duchenne Muscular Dystrophy (DMD)

Interventions

DRUG

GRT6019

Single Dose

Sponsors & Collaborators

  • Grünenthal GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-21
Primary Completion
2026-01-06
Completion
2026-01-06
FDA Drug
Yes

Countries

  • United States

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 NCT07317063 on ClinicalTrials.gov