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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
5
C21 in ascending doses of 15, 50, 150, 500 and 1000 µg
Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control
Clinical Trial Consultants AB
Uppsala, Uppsala Lân, Sweden
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)
Time frame: 85 minutes
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)
Time frame: 85 min
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)
Time frame: 45 minutes
Frequency of Adverse Events
Total number of adverse events was counted
Time frame: Day 1-7
Number of Mild, Moderate, and Severe Adverse Events
Number of mild, moderate, and severe adverse events was counted
Time frame: Day 1-7
Number of Serious Adverse Events (SAEs)
Number of serious adverse events (SAEs) was counted
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: 5 hours