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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031220678
Enrollment
32
Registered
2023-03-03
Start date
2023-03-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic triglyceride deposit cardiomyovasculopathy

Interventions

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.

Sponsors

Akita Yasuhiko
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics

Contacts

Public ContactClinical Development Dept.

TOA EIYO LTD.

ct_info@toaeiyo.co.jp+81-48-647-7975

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026