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

NCT07317063 | Completed Phase 1 FDA Drug

• 1 other identifier: HP6019-10
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Duchenne Muscular Dystrophy (DMD)

Outcome Measures

Primary Outcomes (4)

• Number of participants with Adverse Events

  Assessment of safety and tolerability of GRT6019 after a single oral dose

  Through study completion, an average of 7 Weeks

• Number of participants with serious Adverse Events

  Assessment of safety and tolerability of GRT6019 after a single oral dose

  Through study completion, an average of 7 Weeks

• Number of participants with Adverse Events leading to discontinuation

  Assessment of safety and tolerability of GRT6019 after a single oral dose

  Through study completion, an average of 7 Weeks

• Number of participants with Adverse Events related with GRT6019

  Assessment of safety and tolerability of GRT6019 after a single oral dose

  Through study completion, an average of 7 Weeks

Secondary Outcomes (11)

• Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUC0-t)

  From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

• Area under the concentration-time curve from pre-dose (time 0) extrapolated to infinite time (AUC0-inf )

  From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

• Maximum plasma concentration (Cmax)

  From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

• Time of maximum plasma concentration (Tmax)

  From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

• Lag-time observed from dosing to the time point prior to that of the first quantifiable plasma concentration (Tlag). Assessment of the PK of GRT6019 following a single oral dose of the pediatric formulation under fasted and fed conditions.

  From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

Study Arms (2)

GRT6019 :Cohort 1

EXPERIMENTAL

Fed State

Drug: GRT6019

GRT6019: Cohort 2

EXPERIMENTAL

Fasted State

Drug: GRT6019

Interventions

GRT6019 DRUG

Single Dose

Also known as: Study drug

GRT6019 :Cohort 1; GRT6019: Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• Major surgical procedure, within 3 months prior to ICF signing, or anticipation of need for a major surgical procedure during the trial.
• Clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, or immunological disorder(s) as determined by the investigator.
• Any medication, including herbal remedies or over-the-counter medication within 2 weeks before screening into this trial and anticipated use during the trial.
• 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.
• 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.

Sponsors & Collaborators

• Grünenthal GmbH: lead

Study Sites (1)

Biotrial, Inc

Newark, New Jersey, 07103, United States

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Drug Evaluation

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: November 21, 2025
• Primary Completion: January 6, 2026
• Study Completion: January 6, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)