Duchenne Muscular Dystrophy (DMD)Phase 1NCT07317063
A Trial to Investigate Safety and Pharmacokinetics of GRT6019, Including Food Effect, in Healthy Male Participants
A Phase 1 study testing GRT6019 in people with Duchenne Muscular Dystrophy (DMD), run by Grünenthal GmbH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Duchenne Muscular Dystrophy (DMD)
- What is being tested?
- GRT6019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to 6 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Main inclusion Criteria:
- 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.
- Participants must sign the ICF before any trial-related assessments.
- 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:
- 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.
- 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) as determined by the investigator.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Being tested
- GRT6019
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRT6019Drug
Also called Study drug
Single Dose
| Study group | Role | What they receive |
|---|---|---|
| GRT6019 :Cohort 1 | Experimental | Fed State Receives: Drug: GRT6019 |
| GRT6019: Cohort 2 | Experimental | Fasted State Receives: Drug: GRT6019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
Assessment of safety and tolerability of GRT6019 after a single oral dose
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 7 Weeks
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start21 Nov 2025
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duchenne Muscular Dystrophy (DMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317063
- Sponsor's protocol ID
- HP6019-10
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07317063
- Acronym / sponsor ID
- HP6019-10
- Conditions
- Duchenne Muscular Dystrophy (DMD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRT6019 :Cohort 1 | Experimental | Drug: GRT6019Fed State |
| GRT6019: Cohort 2 | Experimental | Drug: GRT6019Fasted State |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRT6019Also: Study drugSingle Dose | Drug | GRT6019 :Cohort 1, GRT6019: Cohort 2 |
Primary outcome
Number of participants with Adverse Events
Time frame: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with serious Adverse Events
Time frame: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with Adverse Events leading to discontinuation
Time frame: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
Number of participants with Adverse Events related with GRT6019
Time frame: Through study completion, an average of 7 Weeks
Assessment of safety and tolerability of GRT6019 after a single oral dose
11 secondary outcomes
Area under the concentration-time curve from pre-dose (time 0) to the time of the last quantifiable concentration (AUC0-t)
Time frame: 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 )
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Maximum plasma concentration (Cmax)
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Time of maximum plasma concentration (Tmax)
Time frame: 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.
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Terminal elimination half life (T₁/₂)
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Total body oral clearance (CL/F)
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Apparent volume of distribution (V/F)
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of AUC0-t
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of AUC0-inf
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Ratio of the geometric mean of Cmax
Time frame: From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRT6019 in people with Duchenne Muscular Dystrophy (DMD), run by Grünenthal GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: Through study completion, an average of 7 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.