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Completed

NCT Number: NCT05277922

Effect of C21 on Forearm Blood Flow

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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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Consultants AB

Uppsala, Uppsala Lân, 75237, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • History of thrombotic disease, vascular disorder, or severe bleeding disease.
  • Poor brachial artery access.
  • Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of baseline
  • 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.
  • Any planned major surgery within the duration of the study.
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV).
  • Abnormal vital signs
  • Prolonged QT interval, cardiac arrhythmias or any clinically significant abnormalities in the resting ECG
  • 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.
  • Regular use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, vitamins, and minerals
  • Regular use of non-steroidal anti-inflammatory drugs or acetylsalicylic acid
  • Vaccination within 1 week prior to dosing or plans to receive any vaccine during the study conduct.
  • Planned treatment or treatment with another investigational drug within 3 months
  • Current regular smokers or users of nicotine products.
  • History of alcohol abuse
  • Presence or history of drug abuse
  • Positive screen for drugs of abuse or alcohol at screening
  • History of, or current use of, anabolic steroids.
  • Inability to refrain from consuming caffeine-containing beverages during Day 1
  • Plasma donation within 1 month of screening or blood donation (or corresponding blood loss) during the 3 months prior to screening.
  • Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Treatment and study plan

C21

Drug

C21 in ascending doses of 15, 50, 150, 500 and 1000 µg

Other names: Compund 21

Sodium Nitroprusside

Drug

Ascending doses of 4, 8 and 16 µg sodium nitroprusside Positive control

Other names: Nipruss

Primary outcomes

  1. Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intraarterial Doses of C21

    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)

Secondary outcomes

  1. Dose-response Curve of C21 on Forearm Blood Flow (FBF)

    Time frame: 85 min

    Geometric mean forearm blood flow (mL/min) by increasing C21 dose (3, 10, 30, 100, and 200 μg/min)

  2. Percentage Change From Baseline in Forearm Blood Flow in Response to Increasing Intra-arterial Doses of Sodium Nitroprusside

    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)

  3. Frequency of Adverse Events

    Time frame: Day 1-7

    Total number of adverse events was counted

  4. Number of Mild, Moderate, and Severe Adverse Events

    Time frame: Day 1-7

    Number of mild, moderate, and severe adverse events was counted

  5. Number of Serious Adverse Events (SAEs)

    Time frame: Day 1-7

    Number of serious adverse events (SAEs) was counted

  6. Number of Participants With Clinically Significant Changes in Vital Sign Parameters

    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

  7. Number of Participants With Clinically Significant Changes in ECG Parameters

    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

  8. Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters

    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

Sponsors and collaborators

Lead sponsor

Vicore Pharma AB

Industry

Collaborators

  • CTC Clinical Trial Consultants AB

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.