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

JRCT ID: jRCT2031220678

Registered date:03/03/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Idiopathic triglyceride deposit cardiomyovasculopathy
• Date of first enrollment: 10/03/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Digoxin 0.25 mg and Rosuvastatin Calcium 5 mg or CNT-01 1000 mg, Digoxin 0.25 mg and Rosuvastatin Calcium 5 mg are administered orally.

Outcome(s)

• Primary Outcome: Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 40age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Akita Yasuhiko