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| Name | Class |
|---|---|
| CTC Clinical Trial Consultants AB | INDUSTRY |
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The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.
Subject will be screened for eligibility. Eligible subjects will receive ascending doses of C21 (3, 10, 30, 100, and 200 µg/min through local intra-arterial infusions for 5 min/dose. Forearm blood flow measurements will be performed in both arms during the last 2 minutes of each dose.
Infusions of sodium nitroprusside will be performed as a positive control using the same methodology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C21 combined | Experimental | 15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min) |
|
| Positive control | Experimental | 4 µg nitroprusside (infusion rate 0.8 µg/min) 8 µg nitroprusside (infusion rate 1.6 µg/min) 16 µg nitroprusside (infusion rate 3.2 µg/min) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C21 | Drug | C21 in ascending doses of 15, 50, 150, 500 and 1000 µg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21 | Percentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min) | 85 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-response Curve of C21 on Forearm Blood Flow (FBF) | Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min) | 85 min |
| Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Consultants AB | Uppsala | Uppsala Lân | 75237 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38344891 | Derived | Rein-Hedin E, Sjoberg F, Ganslandt C, Skoog J, Zachrisson H, Bengtsson T, Dalsgaard CJ. Utilizing venous occlusion plethysmography to assess vascular effects: A study with buloxibutid, an angiotensin II type 2 receptor agonist. Clin Transl Sci. 2024 Feb;17(2):e13735. doi: 10.1111/cts.13735. |
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5 subjects were enrolled into the trial and all subjects received 5 ascending doses of C21 followed by 3 ascending doses of sodium nitroprusside as a positive control. Thus, the 5 subjects were reused for both C21 and sodium nitroprusside treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | C21 Combined | 15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min) C21: C21 in ascending doses of 15, 50, 150, 500 and 1000 µg |
| FG001 | Positive Control | 4 µg nitroprusside (infusion rate 0.8 µg/min) 8 µg nitroprusside (infusion rate 1.6 µg/min) 16 µg nitroprusside (infusion rate 3.2 µg/min) Sodium Nitroprusside: Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 15 µg C21 |
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| 50 µg C21 |
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| 150 µg C21 |
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| 500 µg C21 |
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| 1000 µg C21 |
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| 4 µg Nitroprusside |
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| 8 µg Nitroprusside |
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| 16 µg Nitroprusside |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | C21 Combined | 15 µg C21 (infusion rate 3 µg/min) 50 µg C21 (infusion rate 10 µg/min) 150 µg C21 (infusion rate 30 µg/min) 500 µg C21 (infusion rate 100 µg/min) 1000 µg C21 (infusion rate 200 µg/min) C21: C21 in ascending doses of 15, 50, 150, 500 and 1000 µg |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21 | Percentage change from baseline in forearm blood flow (FBF) in response to increasing intraarterial doses of C21 (3, 10, 30, 100, and 200 μg/min) | Posted | Mean | Standard Deviation | percentage of change from baseline | 85 minutes |
|
Adverse events were recorded from trial start until end-of-trial contact (follow-up), 7 days after trial start
Adverse events were recorded from trial start until end-of-trial contact (follow-up),
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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 Group | Participants infused with increasing doses of C21 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site bruising | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecilia Ganslandt | Vicore Pharma AB | +46 705 797075 | 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 9, 2022 | Mar 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000711730 | compound 21 |
| D009599 | Nitroprusside |
| ID | Term |
|---|---|
| D005292 | Ferricyanides |
| D003486 | Cyanides |
| D000838 | Anions |
| D007477 | Ions |
| D004573 |
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Subjects will receive increasing doses of C21
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| Sodium Nitroprusside | Drug | Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control |
|
|
Percentage change from baseline in forearm blood flow in response to increasing intra-arterial doses of sodium nitroprusside (0.8, 1.6, and 3.2 μg/min) |
| 45 minutes |
| Frequency of Adverse Events | Total number of adverse events was counted | Day 1-7 |
| Number of Mild, Moderate, and Severe Adverse Events | Number of mild, moderate, and severe adverse events was counted | Day 1-7 |
| Number of Serious Adverse Events (SAEs) | Number of serious adverse events (SAEs) was counted | Day 1-7 |
| Number of Participants With Clinically Significant Changes in Vital Sign Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean systolic blood pressure, diastolic blood pressure or pulse rate were counted | 5 hours |
| Number of Participants With Clinically Significant Changes in ECG Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted | 5 hours |
| Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment (Day 1) in mean clinical chemistry, haematology or coagulation parameters were counted | 5 hours |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index | Mean | Standard Deviation | kg/m2 |
|
Third dose of C21: 30 ug/min
| OG003 | C21 100 ug/Min | Fourth dose of C21: 100 ug/min |
| OG004 | C21 200 ug/Min | Last dose of C21: 200 ug/min |
|
|
| Secondary | Dose-response Curve of C21 on Forearm Blood Flow (FBF) | Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min) | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | 85 min |
|
|
|
|
| Secondary | Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside | Percentage change from baseline in forearm blood flow in response to increasing intra-arterial doses of sodium nitroprusside (0.8, 1.6, and 3.2 μg/min) | Posted | Mean | Standard Deviation | percentage of change from baseline | 45 minutes |
|
|
|
| Secondary | Frequency of Adverse Events | Total number of adverse events was counted | Posted | Number | Number of adverse events | Day 1-7 |
|
|
|
| Secondary | Number of Mild, Moderate, and Severe Adverse Events | Number of mild, moderate, and severe adverse events was counted | Posted | Number | Number of events | Day 1-7 |
|
|
|
| Secondary | Number of Serious Adverse Events (SAEs) | Number of serious adverse events (SAEs) was counted | Posted | Number | Number of SAEs | Day 1-7 |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Vital Sign Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean systolic blood pressure, diastolic blood pressure or pulse rate were counted | Posted | Count of Participants | Participants | 5 hours |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in ECG Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted | Posted | Count of Participants | Participants | 5 hours |
|
|
|
| Secondary | Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters | Participants with Clinically significant changes from baseline (screening ) to the end of treatment (Day 1) in mean clinical chemistry, haematology or coagulation parameters were counted | Posted | Count of Participants | Participants | 5 hours |
|
|
|
| 5 |
| 0 |
| 5 |
| 2 |
| 5 |
| EG001 | Total | All participants (infused with C21 and nitroprusside) | 0 | 5 | 0 | 5 | 2 | 5 |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (24.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
|
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| Electrolytes |
| D007287 | Inorganic Chemicals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D006856 | Hydrogen Cyanide |
| D017672 | Nitrogen Compounds |
| Geometric mean ratio |
| 1.2454 |
| 2-Sided |
| 95 |
| 1.0355 |
| 1.4979 |
| Superiority |
| Geometric mean ratio | 1.2392 | 2-Sided | 95 | 1.0304 | 1.4904 | Superiority |
| Geometric mean ratio | 1.2394 | 2-Sided | 95 | 1.0305 | 1.4906 | Superiority |
| Geometric mean ratio | 0.9950 | 2-Sided | 95 | 0.8273 | 1.1967 | Superiority |
| Geometric mean ratio | 1.5058 | 2-Sided | 95 | 1.2520 | 1.8110 | Superiority |
| Geometric mean ratio | 1.5060 | 2-Sided | 95 | 1.2522 | 1.8113 | Superiority |
| Geometric mean ratio | 1.2091 | 2-Sided | 95 | 1.0053 | 1.4541 | Superiority |
| Geometric mean ratio | 1.2151 | 2-Sided | 95 | 1.0103 | 1.4614 | Superiority |
| Geometric mean ratio | 1.2456 | 2-Sided | 95 | 1.0357 | 1.4981 | Superiority |
| Number of severe AEs |
|