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Completed

NCT Number: NCT02502578

Safety Study of CNT-01 in Patients With Idiopathic TGCV

The purpose of this study is to assess the safety and to examine the index of the efficacy after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit cardiomyovasculopathy.

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Key information

Conditions

Idiopathic Triglyceride Deposit Cardiomyovasculopathy

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cardiovascular Medicine, Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy
  • After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient
  • More than 20 years old at the time of informed consent
  • Is able to oral intake
  • Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy

Exclusion criteria

  • Have diabetic ketoacidosis
  • Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years
  • Female with pregnant or lactating
  • 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
  • Have a New York Heart Association functional classification IV
  • Have a known history of drug dependence
  • Is allergic to any component of the investigational product
  • Is allergic to BMIPP or iodine
  • Have a known history of clinically significant drug allergy
  • Have a severe liver dysfunction (Child classification B and C)
  • Participated in other clinical study within the past 3 months and received an investigational agent including placebo
  • Being treated with diet containing medium chain fatty acid
  • Is considered unfit for the study by the Investigator's medical decision

Treatment and study plan

CNT-01 500 mg capsule

Drug

After being informed about the study and potential risks, all patients giving written informed consent undergo screening tests to determine eligibility for study enrollment. On Day 1, patients who meet the eligibility criteria will start taking CNT-01 500mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.

Primary outcomes

  1. Number of adverse event

    Time frame: Baseline to Day 29

  2. Change in 12-lead ECG recordings from Baseline

    Time frame: Baseline to Day 29

  3. Change in Blood Pressure from Baseline

    Time frame: Baseline to Day 29

  4. Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)

    Time frame: Baseline to Day 29

  5. Change in Body temperature from Baseline

    Time frame: Baseline to Day 29

  6. Change in Pulse rate from Baseline

    Time frame: Baseline to Day 29

Secondary outcomes

  1. Change in uptake and washout rate in BMIPP myocardial scintigraphy

    Time frame: Baseline to Day 15

  2. Change in blood concentration of fatty acid fraction from Baseline (Octanoic acid, Capric acid, Myristic acid, Palmitic acid and Stearic acid)

    Time frame: Baseline to Day 16

  3. Change in lipase activity in peripheral polynuclear leucocyte from Baseline

    Time frame: Baseline to Day 29

  4. Change in blood lipoprotein fraction from Baseline

    Time frame: Baseline to Day 29

  5. Change in vacuolation rate in polynuclear leucocyte from Baseline

    Time frame: Baseline to Day 29

  6. Change in frequency in use of nitroglycerin from Baseline

    Time frame: Baseline to Day 29

  7. Change in New York Heart Association (NYHA) functional classification from Baseline

    Time frame: Baseline to Day 29

  8. Change in reactive hyperemic index from Baseline

    Time frame: Baseline to Day 29

  9. Change in score of SF-36 from Baseline

    Time frame: Baseline to Day 29

Sponsors and collaborators

Lead sponsor

Osaka University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
First posted
Jul 20, 2015
Registry last updated
Sep 28, 2016

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.