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

NCT07347548 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: HP6019-07
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy (DMD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Area under the concentration-time curve over the dosing interval (AUCtau)

  Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)

• Maximum observed concentration (Cmax)

  Following the first dose (Day 1), then at Day 14, and after the last dose (Day 28)

Study Arms (3)

GRT6019: Cohort 1

EXPERIMENTAL

4 weeks dosing with GRT6019 low dose once a day \[QD\]

Drug: GRT6019

GRT6019: Cohort 2

EXPERIMENTAL

4 weeks dosing with GRT6019 medium dose once a day \[QD\]

Drug: GRT6019

GRT6019: Cohort 3

EXPERIMENTAL

4 weeks dosing with GRT6019 higher dose once a day \[QD\]

Drug: GRT6019

Interventions

GRT6019 DRUG

Multiple dose (MD)

GRT6019: Cohort 1; GRT6019: Cohort 2; GRT6019: Cohort 3

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• Participant must sign the informed consent form 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 participant 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)
• 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
• 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 Clinical Pharmacology Unit

Rennes, 35042, France

Location

Related Links

• Clinical trial transparency at Grünenthal

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

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

Study Design

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

Model Details: Cohorts 1 and 2 will be dosed in parallel, followed by Cohort 3 sequentially

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: January 6, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)