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

An Open-label, Single-center Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of a Single Dose of GRT6019, Including Food Effect, in Healthy Male Participants

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

Study Overview

• Status: Completed
• Conditions: Duchenne Muscular Dystrophy (DMD)
• Intervention / Treatment: Drug: GRT6019

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

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Biotrial, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Main 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.
3. The participant is in good health as determined by the medical history, physical examination, 12-lead Electrocardiogram (ECG), vital signs (heart rate [HR], respiratory rate [RR], systolic and diastolic blood pressure [BP]), body temperature, and clinical laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis) without clinically relevant (per investigator judgement) deviations from reference ranges unless further specified in the exclusion criteria.

Main 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRT6019 :Cohort 1; Fed State	Drug: GRT6019; Single Dose; Other Names: Study drug
Experimental: GRT6019: Cohort 2; Fasted State	Drug: GRT6019; Single Dose; Other Names: Study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUC0-t)	The total amount of the study drug in the blood from the time it is taken until the last time a measurable level of the drug is found. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	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 )	The total amount of the study drug in the blood from the time it is taken until it has completely left the body. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Maximum plasma concentration (Cmax)	The maximum amount of the study drug measured in the blood after taking the dose. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Time of maximum plasma concentration (Tmax)	The time it takes to reach the highest concentration of the study drug in the blood after dosing. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	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.	The time between when the study drug is taken and when it first becomes measurable in the blood. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Terminal elimination half life (T₁/₂)	The time it takes for the amount of study drug in the blood to reduce by half after reaching its peak level. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Total body oral clearance (CL/F)	The amount of blood completely cleared of thestudy drug (and metabolite) per unit of time, taking into account how much of the drug is absorbed into the body. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Apparent volume of distribution (V/F)	An estimate of how widely the study drug spreads through the body's tissues after it is absorbed. Assessment of the PK of GRT6019 following a single dose under fasted and fed conditions.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of AUC0-t	Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of AUC0-inf	Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of Cmax	Assessment of the effect of food (fed and fasted state) on the PK of GRT6019 following a single dose.	From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: December 19, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Muscular Disorders, Atrophic; Muscular Dystrophies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Muscular Dystrophy, Duchenne; Investigative Techniques; Evaluation Studies as Topic; Drug Development; Drug Evaluation
• Other Study ID Numbers: HP6019-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No