Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy

Phase 1

• Conditions: Idiopathic Triglyceride Deposit Cardiomyovasculopathy

• Registration Number: JPRN-UMIN000018289
• Lead Sponsor: Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-14
• Study Completion: 2016-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

1) Have diabetic ketoacidosis 2) Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years 3) Female with pregnant or lactating 4) Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study 5) Have a New York Heart Association functional classification IV 6) Have a known history of drug dependence 7) Is allergic to any component of the investigational product 8) Is allergic to BMIPP or iodine 9) Have a known history of clinically significant drug allergy 10) Have a severe liver dysfunction (Child classification B and C) 11) Participated in other clinical study within the past 3 months and received an investigational agent including placebo 12) Being treated with diet containing medium chain fatty acid 13) Is considered unfit for the study by the Investigator's medical decision

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Adverse event -Change in ECG parameters from Baseline (QTc, QT, QRS) -Change in vital signs from Baseline (Body temperature, Blood pressure, Pulse rate) -Change in clinical laboratory data from Baseline (Hematology, Serum chemistry, Urinalysis)

Secondary Outcome Measures

Name	Time	Method
-Change in uptake and washout rate in BMIPP myocardial scintigraphy -Change in blood concentration of fatty acid fraction from Baseline -Change in lipase activity in peripheral polynuclear leucocyte from Baseline -Change in blood lipoprotein fraction from Baseline (Total cholesterol in Chylomicron, VLDL, LDL, HDL, Triglyceride in Chylomicron, VLDL, LDL, HDL) -Change in vacuolation rate in polynuclear leucocyte from Baseline -Change in frequency in use of nitroglycerin from Baseline -Change in New York Heart Association (NYHA) functional classification from Baseline -Change in vascular endothelial function from Baseline (Reactive hyperemic index) -Change in score of SF-36 from Baseline