Clinical Trial Consultants AB
Uppsala, Uppsala Lân, 75237, Sweden
NCT Number: NCT05277922
The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Uppsala, Uppsala Lân, 75237, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
C21 in ascending doses of 15, 50, 150, 500 and 1000 µg
Other names: Compund 21
Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control
Other names: Nipruss
Time frame: 85 minutes
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)
Time frame: 85 min
Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min)
Time frame: 45 minutes
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)
Time frame: Day 1-7
Total number of adverse events was counted
Time frame: Day 1-7
Number of mild, moderate, and severe adverse events was counted
Time frame: Day 1-7
Number of serious adverse events (SAEs) was counted
Time frame: 5 hours
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
Time frame: 5 hours
Participants with Clinically significant changes from baseline (screening ) to the end of treatment in mean values of the ECG parameters were counted
Time frame: 5 hours
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
Vicore Pharma AB
Industry
A Phase 1, Open-label, Single-centre Study Investigating the Effect of C21 on Forearm Blood Flow in Healthy Male Subjects by Use of Strain-gauge Venous Occlusion Plethysmography
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.