JPRN-jRCT2031220678
Completed
Phase 2
Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01
Akita Yasuhiko0 sites32 target enrollmentMarch 3, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Idiopathic triglyceride deposit cardiomyovasculopathy
- Sponsor
- Akita Yasuhiko
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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