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

An Open-label, Single-center, 4-week Phase I Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of GRT6019 in Healthy Male Participants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Duchenne Muscular Dystrophy (DMD)
• Intervention / Treatment: Drug: GRT6019

Detailed Description

There are 8 participants planned per cohort to ensure sufficient sample size for a reliable estimate of PK parameters.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
    • Biotrial Clinical Pharmacology Unit

Participation Criteria

Eligibility Criteria

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

Description

Main Inclusion Criteria:

1. Participant must be male, 18 to 55 years of age (inclusive) at the time of signing the informed consent form and affiliated to the social security system.
2. Participant must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
3. Participant must sign the informed consent form before any trial-related assessments.
4. The participant is in good health as determined by the medical history, physical examination, 12-lead ECG, vital signs (heart rate, respiratory rate, 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. The population of this clinical trial is healthy volunteer participants.

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 participant 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)
4. Regularly uses 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: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRT6019: Cohort 1; 4 weeks dosing with GRT6019 low dose once a day [QD]	Drug: GRT6019; Multiple dose (MD)
Experimental: GRT6019: Cohort 2; 4 weeks dosing with GRT6019 medium dose once a day [QD]	Drug: GRT6019; Multiple dose (MD)
Experimental: GRT6019: Cohort 3; 4 weeks dosing with GRT6019 higher dose once a day [QD]	Drug: GRT6019; Multiple dose (MD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AEs)	Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment	Through study completion, an average of 4 Weeks
Number of participants with Serious Adverse Events (SAEs)	Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment	Through study completion, an average of 4 Weeks
Number of participants with AEs leading to discontinuation	Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment	Through study completion, an average of 4 Weeks
Number of participants with AEs related to investigational medicinal product [IMP]	Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment	Through study completion, an average of 4 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the concentration-time curve over the dosing interval (AUCtau)	Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment	Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)
Maximum observed concentration (Cmax)	Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment	Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)

Collaborators and Investigators

• Sponsor: Grünenthal GmbH

Publications and helpful links

Helpful Links

• Clinical trial transparency at Grünenthal

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 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
• Other Study ID Numbers: HP6019-07

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