Phase I Clinical Study -Multiple Dose Study of CNT-01-

JRCT ID: jRCT2071210012

Registered date:14/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic triglyceride deposit cardiomyovasculopathy
• Date of first enrollment: 19/04/2021
• Target sample size: 42
• Study type: Interventional

Intervention(s)

Study drug: CNT-01 500 mg, 1500 mg or 4500 mg is administered orally as a single dose or three times daily for 7 days.
Control drug: CNT-01 placebo is administered orally as a single dose or three times daily for 7 days.

Outcome(s)

• Primary Outcome: Pharmacokinetics, Effect on QTcF and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

1) Subjects who signed the written informed consent
2) Age>=20 and =<40 at time of consent
3) Weight>=45kg, height>=140 cm, and body mass index (BMI) >=18.5 and <25.0 at screening

Exclude criteria

1) Subjects with complications such as medically significant gastrointestinal, renal, respiratory, endocrine, hematological, nervous, psychiatric, cardiovascular, or congenital metabolic abnormalities.
2) Subjects with acute illness within 2 weeks prior to administration of the investigational drug.
3) Subjects with a current or past history of drug or food allergy.
4) Subjects with QTcF of 450 msec or more, PR interval of 220 msec or more, or QRS width of 120 msec or more on 12-lead ECG performed before administration on Day 1.
5) Subjects with a history of syncope.
6) Subjects with family history of congenital long QT syndrome or sudden cardiac death.
7) Patients with a history of infection requiring treatment within 4 weeks prior to administration of the investigational drug.
8) Persons with a positive SARS-CoV-2 test (nucleic acid amplification test) or suspected COVID-19 test performed within 3 days before admission to the hospital.

Related Information

• Primary Sponsor: Akita Yasuhiko