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Safety Study of CNT-01 in Patients With Idiopathic TGCV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502578
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ken-ichi Hirano, Osaka University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Idiopathic Triglyceride Deposit Cardiomyovasculopathy Drug: CNT-01 500 mg capsule Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa Study of CNT-01 in Patients With Idiopathic Triglyceride Deposit
Study Start Date : September 2015
Actual Primary Completion Date : June 2016

Arm Intervention/treatment
Experimental: CNT-01
Patients will receive CNT-01 500 mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
Drug: CNT-01 500 mg capsule
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502578


Locations
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Japan
Cardiovascular Medicine, Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Investigators
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Study Chair: Ken-ichi Hirano, M.D., Ph.D. Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine
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Responsible Party: Ken-ichi Hirano, Assistant Professor, Osaka University
ClinicalTrials.gov Identifier: NCT02502578    
Other Study ID Numbers: CNT-01-001
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Ken-ichi Hirano, Osaka University:
Triglyceride Deposit Cardiomyovasculopathy