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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-000168-77 | EudraCT Number |
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This trial is a single-centre, randomized, double-blind, placebo-controlled, 2-way cross-over phase 1b trial evaluating the pharmacodynamic effect of C21 on endothelial dysfunction and safety in subjects with type 2 diabetes mellitus (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm 1 | Experimental | A single dose of C21 at visit 2 followed by a single dose of placebo at visit 3. |
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| Treatment arm 2 | Experimental | A single dose of placebo at visit 2 followed by a single dose C21 at visit 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C21 | Drug | C21 is an angiotensin II type 2 receptor agonist (ATRAG) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic Effect | Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). The EndoPAT software, provided with the device, is calculating the RHI using a computerised, automated algorithm. Reactive Hyperemia Index (RHI) score is a post-to-pre occlusion pulse amplitude tonometry signal ratio in the occluded arm relative to the same ratio in the control arm, and corrected for baseline vascular tone. RHI is a measure of endothelial function. Normal value: RHI > 1.67. Abnormal value: RHI ≤ 1.67. There is no theoretical minimum and/or maximum values for the RHI score. A lower RHI score following C21 compared to placebo is the desired outcome. | Maximum 15 days after first Investigational Medical Product (IMP) intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Augmentation Index (AI) Score as Measured by EndoPAT (Endothelial Pulse Amplitude Tonometry (PAT)). The AI Score Reported is Change Between Baseline Value and Value at the Visit Where Either C21 or Placebo is Taken. | The EndoPAT software, provided with the device is calculating the the Augmentation index (AI) using a computerised, automated algorithm. Augmentation index is a measurement of vascular stiffness. Augmentation index is calculated from PAT pulses based on the following formula AIx = 100 × (Augmentation pressure)/(Pulse Pressure). Ideally the augmentation index is somewhere between 20-80, but can be both negative and positive depending on the value of the augmentation pressure. A higher value is indicative of vascular stiffness. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skånes universitetssjukhus | Malmö | 20502 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: C21 First, Then Placebo | Participants first received a single oral dose of C21. After a washout period of 3 to 14 days, they then received a single oral dose of placebo (matching the C21 tablet). |
| FG001 | Experimental: Placebo First, Then C21 | Participants first received a single oral dose of placebo (matching the C21 tablet). After a washout period of 3 to 14 days, they then received a single oral dose of C21. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout Between 1st and 2nd Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: C21 First, Then Placebo | Participants first received a single oral dose of C21. After a washout period of 3 to 14 days, they then received a single oral dose of placebo (matching the C21 tablet). |
| BG001 | Experimental: Placebo First, Then C21 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacodynamic Effect | Reactive hyperemia index (RHI) score as measured by EndoPAT (Endothelial pulse amplitude tonometry (PAT)). The EndoPAT software, provided with the device, is calculating the RHI using a computerised, automated algorithm. Reactive Hyperemia Index (RHI) score is a post-to-pre occlusion pulse amplitude tonometry signal ratio in the occluded arm relative to the same ratio in the control arm, and corrected for baseline vascular tone. RHI is a measure of endothelial function. Normal value: RHI > 1.67. Abnormal value: RHI ≤ 1.67. There is no theoretical minimum and/or maximum values for the RHI score. A lower RHI score following C21 compared to placebo is the desired outcome. | Posted | Mean | Standard Error | score on a scale | Maximum 15 days after first Investigational Medical Product (IMP) intake. |
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All events meeting the definition of an AE was reported in the period from the subject has signed the informed consent form (screening visit) until the end-of-trial visit. Depending on visit schedule this period can be up to 49 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | C21 Treatment | Subjects received a single dose of 200 mg C21 (4 oral capsules) at Visit 2 or Visit 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clincial Operations | Vicore Pharma AB | +46 (0) 31 788 05 60 | info@vicorepharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2023 | Apr 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000711730 | compound 21 |
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| Maximum 15 days after first Investigational Medical Product (IMP) intake. |
| NOT COMPLETED |
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| NOT COMPLETED |
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Participants first received a single oral dose of placebo (matching the C21 tablet). After a washout period of 3 to 14 days, they then received a single oral dose of C21. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Placebo Treatment | Subjects received a single dose (4 oral capsules) of placebo at Visit 2 or Visit 3. |
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| Secondary | Augmentation Index (AI) Score as Measured by EndoPAT (Endothelial Pulse Amplitude Tonometry (PAT)). The AI Score Reported is Change Between Baseline Value and Value at the Visit Where Either C21 or Placebo is Taken. | The EndoPAT software, provided with the device is calculating the the Augmentation index (AI) using a computerised, automated algorithm. Augmentation index is a measurement of vascular stiffness. Augmentation index is calculated from PAT pulses based on the following formula AIx = 100 × (Augmentation pressure)/(Pulse Pressure). Ideally the augmentation index is somewhere between 20-80, but can be both negative and positive depending on the value of the augmentation pressure. A higher value is indicative of vascular stiffness. | Posted | Mean | Standard Error | score on a scale | Maximum 15 days after first Investigational Medical Product (IMP) intake. |
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| 0 |
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Placebo Treatment | Subjects received a single dose (4 oral capsules) of placebo at Visit 2 or Visit 3. | 0 | 11 | 0 | 11 | 1 | 11 |
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Transaminases increased | Investigations | Systematic Assessment |
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