An open-label, dose escalation, multicenter study to determine the effect on coronary blood flow and safety of NMB46 in subjects undergoing a clinically indicated cardiac catheterization.

Phase 2

Completed

• Conditions: Subjects who are planned to be undergoing a clinically indicated cardiac catheterization

• Registration Number: JPRN-jRCT2080224182
• Lead Sponsor: ihon Medi-Physics Co., Ltd.

Brief Summary

Efficacy and safety results suggested that a single intravenous bolus of 400 microgram NMB46 had a sufficient coronary blood flow-increasing effect on visualizing the ischemic region during MPI. Also, considering there was no problem with safety, we decided to consider 400 microgram as the evaluation dose for the next phase study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-11
• Study Completion: 2020-02-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Included un the study will be subjects who:
1. Are undergoing a clinically indicated cardiac catheterization for evaluation and/ or treatment of suspected ischemic heart disease
2. Have a normal ECG or an abnormal ECG not considered to reflect ongoing or frequently recurrent ischemia at screening

Exclusion Criteria

Exclusion from the study will be subjects who:
1. Have a history of coronary revascularization by either PCI or CABG within 6 months prior to dosing
2. Have a documented history of acute myocardial infarction or unstable angina within 1 month of dosing
3. Have uncontrolled hypertension
4. Have LVEF < 35%
5. Have aortic stenosis with valve area < 1.5 cm2
6. Have decompensated CHF and/ or New York Heart Association Class IV CHF
7. Have hypertrophic obstructive cardiomyopathy
8. Have asthma , chronic obstructive pulmonary disease or other reactive airway disease for which they are currently receiving treatment
9. Have a history of cardiac transplantation
10. Have a documented history or family history of long QT syndrome
11. Have a documented hypersensitivity to adenosine
12. Have a second- or third-degree AV block
13. Have a sinus node disease, such as sick sinus syndrome or symptomatic bradycardia
14. Have a severe hypotension
15. Known or suspected bronchoconstrictive or bronchospastic lung disease
16. Are unwilling to refrain from all long-acting vasodilating medications
17. Have demonstrable allergy to aminophylline, including allergy to its components (ethylenediamine and theophylline)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Efficacy<br>The time (in seconds) that the ratio of APV to baseline APV following administration of NMB46 will be at least 2.0-fold.

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>1.Efficacy<br>2.Safety<br>1.Efficacy<br>The ratio of peak APV to baseline APV following administration of NMB46<br>The time required for reaching the peak APV after NMB46 administration<br>(Ratio of peak APV to baseline APV following administration of NMB46) / (ratio of peak APV to baseline APV following administration of adenosine)<br><br>2.Safety <br>Adverse event<br>Vital sign <br>12-lead ECG <br>Laboratory tests<br>Examination