Healthy men test drug for muscular dystrophy
NCT ID NCT07317063
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested a single dose of the study drug GRT6019 in 18 healthy men to check its safety and how the body processes it. The study also looked at whether food changes drug absorption. Results will guide future research for Duchenne muscular dystrophy, but this trial did not test the drug in patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Nov 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Biotrial, Inc
Newark, New Jersey, 07103, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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