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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
Cohort 1 and Cohort 2 will be dosed in parallel:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GRT6019 :Cohort 1 | Experimental | Fed State |
|
| GRT6019: Cohort 2 | Experimental | Fasted State |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRT6019 | Drug | Single Dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Assessment of safety and tolerability of GRT6019 after a single oral dose | 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 | 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 | 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 | Through study completion, an average of 7 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose. |
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Main inclusion Criteria:
Main exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial, Inc | Newark | New Jersey | 07103 | United States |
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| ID | Term |
|---|---|
| D020388 | Muscular Dystrophy, Duchenne |
| ID | Term |
|---|---|
| D009136 | Muscular Dystrophies |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From pre-dose (at -2 hours to -5 minutes ) to 528 hours post-dose. |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |