臨床研究等提出・公開システム

Date of registration	Mar. 03, 2023
Last modified on	Jan. 22, 2024
Trial ID	jRCT2031220678

Scientific Title	Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01-
Public Title	Clinical Pharmacology Study -Drug-Drug Interaction Study of CNT-01-

Contact for Scientific Queries	Name	Akita Yasuhiko
	Affiliation	TOA EIYO LTD.
	Address	2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA
	Telephone	+81-48-647-7975
	E-mail	ct_info@toaeiyo.co.jp
Contact for Public Queries	Name	Clinical Development Dept.
	Affiliation	TOA EIYO LTD.
	Address	2-293-3, Amanuma-cho, Omiya-ku, Saitama-shi, SAITAMA
	Telephone	+81-48-647-7975
	E-mail	ct_info@toaeiyo.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 10, 2023
Actual date of first enrollment		Mar. 10, 2023
Target sample size		32
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion 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.
	Age Minimum	18age old over
	Age Maximum	40age old under
	Gender	Male
Health Condition(s) or Problem(s) Studied		Idiopathic triglyceride deposit cardiomyovasculopathy
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.
Primary Outcome(s)		Pharmacokinetics

Primary Sponsor	TOA EIYO LTD.

Name of Certified Review Board	HOUEIKAI Institutional Review Board
Address	3-28-3,Ikebukuro,Tosima-ku, Tokyo
Telephone	+81-3-5396-4530
E-Mail	kanai_shinichiro@seri.co.jp
Approval Status	Approval
Date of approval	Mar. 09, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Jan. 22, 2024	(this page)	Changes
1	Mar. 03, 2023	Detail

List of change history