Safety Study of CNT-01 in Patients With Idiopathic TGCV

September 27, 2016 updated by: Ken-ichi Hirano, Osaka University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 565-0871
        • Cardiovascular Medicine, Osaka University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of adverse event
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in 12-lead ECG recordings from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in Blood Pressure from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in clinical laboratory testings as measured by serum chemistry, hematology and urinalysis from Baseline (composite)
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in Body temperature from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in Pulse rate from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in uptake and washout rate in BMIPP myocardial scintigraphy
Time Frame: Baseline to Day 15
Baseline to Day 15
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
Baseline to Day 16
Change in lipase activity in peripheral polynuclear leucocyte from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in blood lipoprotein fraction from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in vacuolation rate in polynuclear leucocyte from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in frequency in use of nitroglycerin from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in New York Heart Association (NYHA) functional classification from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in reactive hyperemic index from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29
Change in score of SF-36 from Baseline
Time Frame: Baseline to Day 29
Baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Osaka University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ken-ichi Hirano, M.D., Ph.D., Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNT-01-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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