Effect of C21 on Forearm Blood Flow

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

The purpose of this study is to assess the effect of C21 on forearm blood flow by use of strain-gauge venous occlusion plethysmography.

Study Overview

• Status: Completed
• Conditions: Study Vasodilatory Effects of C21
• Intervention / Treatment: Drug: C21; Drug: Sodium Nitroprusside

Detailed Description

Subject will be screened for eligibility. Eligible subjects will receive ascending doses of C21 (3, 10, 30 and 100 µg/min through locla i.a. 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
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Uppsala Lân
    • Uppsala, Uppsala Lân, Sweden, 75237
      • Clinical Trial Consultants AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study and to comply with study requirements.
2. Healthy male subject aged 18-45 years
3. Body mass index ≥ 18.5 and ≤ 30.0 kg/m2.
4. Wlling to use condom or be vasectomised or practice sexual abstinence
5. Clinically normal medical history, physical findings, vital signs, ECG and laboratory values

Exclusion Criteria:

1. History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. History of thrombotic disease, vascular disorder, or severe bleeding disease.
3. Poor brachial artery access.
4. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline
5. Malignancy within the past 5 years with the exception of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
6. Any planned major surgery within the duration of the study.
7. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
8. Abnormal vital signs
9. Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG
10. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to the IMPs, including any of the excipients of the IMPs.
11. Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals
12. Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid
13. Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.
14. Planned treatment or treatment with another investigational drug within 3 months
15. Current regular smokers or users of nicotine products.
16. History of alcohol abuse
17. Presence or history of drug abuse
18. Positive screen for drugs of abuse or alcohol at screening
19. History of, or current use of, anabolic steroids.
20. Inability to refrain from consuming caffeine-containing beverages during Day 1
21. Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
22. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: C21; 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)	Drug: C21; C21 in ascending doses of 15, 50, 150, 500 and 1000 µg; Other Names: Compund 21
Experimental: Control group; 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)	Drug: Sodium Nitroprusside; Ascending doses of 4, 8 and 16 µg; Other Names: Nipruss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in forearm blood flow in response to increasing intraarterial doses of C21	85 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in forearm blood flow in response to increasing intra arterial doses of sodium nitroprusside	45 minutes
Frequency of adverse events	Day 7
Intensity of adverse events	Day 7
Seriousness of adverse events	Day 7
Clinically significant changes in vital sign parameters	5 hours
Clinically significant changes in ECG parameters	5 hours
Clinically significant changes in safety laboratory parameters	5 hours

Collaborators and Investigators

• Sponsor: Vicore Pharma AB
• Collaborators: CTC Clinical Trial Consultants AB

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: March 3, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Nitric Oxide Donors; Nitroprusside
• Other Study ID Numbers: VP-C21-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No