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Completed

NCT Number: NCT07347548

A Trial to Investigate the Safety and Pharmacokinetics 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.

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Key information

Conditions

Duchenne Muscular Dystrophy (DMD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial Clinical Pharmacology Unit

Rennes, 35042, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • 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.
  • 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:

  • 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

Treatment and study plan

GRT6019

Drug

Multiple dose (MD)

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Through study completion, an average of 4 Weeks

    Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Through study completion, an average of 4 Weeks

    Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment

  3. Number of participants with AEs leading to discontinuation

    Time frame: Through study completion, an average of 4 Weeks

    Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment

  4. Number of participants with AEs related to investigational medicinal product [IMP]

    Time frame: Through study completion, an average of 4 Weeks

    Assessment of safety and tolerability of GRT6019 following 4 weeks of treatment

Secondary outcomes

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

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

    Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment

  2. Maximum observed concentration (Cmax)

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

    Assessment of the pharmacokinetics (PK) of GRT6019 following 4 weeks of treatment, including dose proportionality assessment and investigation of steady state attainment

Sponsors and collaborators

Lead sponsor

Grünenthal GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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