Safety Study of CNT-01 in Patients With Idiopathic TGCV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Idiopathic Triglyceride Deposit Cardiomyovasculopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CNT-01 500 mg capsule

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No