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

NCT ID: NCT07317063

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-21
• Study Completion Date: 2026-01-06

Brief 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

Detailed Description

Cohort 1 and Cohort 2 will be dosed in parallel:

• Cohort 1 (n = 9): single dose of GRT6019 in participants in a fed state
• Cohort 2 (n = 9): single dose of GRT6019 in participants in a fasted state

Conditions

Duchenne Muscular Dystrophy (DMD)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Fed State

Group Type: EXPERIMENTAL

GRT6019

Intervention Type: DRUG

Single Dose

Cohort 2

Fasted State

Group Type: EXPERIMENTAL

GRT6019

Intervention Type: DRUG

Single Dose

Interventions

GRT6019

Single Dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The participant must be able to give signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

2. Participants must sign the ICF before any trial-related assessments.

Exclusion Criteria

1. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, comparator, rescue medication, or any ingredients therein, or may affect the interpretation of the results, or may render the patient at high risk from treatment complications/ participation in the study unsafe.

2. Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.

3. Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s) as determined by the investigator.

4. Any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial.

5. Concurrent enrollment in another clinical trial unless it is an observational (non-interventional) clinical trial or during the Follow-up Period of an interventional trial.

6. Recent participation in another clinical trial with an IMP administered within 30 days before Day 1 OR within 5 times the elimination half-life of the IMP, whichever is longer.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Grünenthal GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biotrial, Inc

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Grünenthal Clinical Trial Helpdesk

Role: CONTACT

clinical-trials@grunenthal.com

+49 241 569 3223

Director Clinical Trials

Role: CONTACT

clinical-trials@grunenthal.com

Facility Contacts

Grissel Flores, MD

Role: primary

973-388-2848

Other Identifiers

HP6019-10

Identifier Type: -

Identifier Source: org_study_id