Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01

Phase 2

• Conditions: Idiopathic triglyceride deposit cardiomyovasculopathy

• Registration Number: JPRN-jRCT2031220678
• Lead Sponsor: Akita Yasuhiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-03
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

1) Subjects who have signed the written informed consent.
2) Subjects 18 to 40 years of age at time of informed consent.
3) Subjects with body weight >=50 kg and body mass index (BMI) of 18.5 to 25.0 kg/m2 (inclusive) at the Screening Visit.

Exclusion Criteria

1) Subjects with complications or past history of medically significant gastrointestinal, renal, respiratory, endocrine, hematological, nervous system, psychiatric, cardiovascular, or congenital metabolic disorders.
2) Subjects with acute illness within 2 weeks prior to administration of the drugs used in the Clinical Trial.
3) Subjects with a current or past history of drug or food allergy.
4) Subjects whose serum potassium or magnesium levels are below the institutional normal ranges at the Screening Visit.
5) Subjects whose serum calcium level is above the institutional normal range at the Screening Visit.
6) Subjects whose serum thyroid stimulating hormone, free triiodothyronine, or thyroxine levels are above the institutional normal ranges at the Screening Visit.
7) Subjects with a history of infection requiring treatment within 4 weeks prior to administration of the drugs used in the Clinical Trial.
8) Subjects with a positive SARS-CoV-2 test (nucleic acid amplification test) performed within 3 days before admission to the clinical site or suspected COVID-19 infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics