臨床研究等提出・公開システム

Date of registration	Dec. 27, 2024
Last modified on	Dec. 27, 2024
Trial ID	jRCT2031240587

Scientific Title	A Phase 1 Study to Evaluate the Relative Bioavailability of Ensitrelvir Granules and 125 mg Tablets, and the Food Effect of Granules (COVID-19)
Public Title	A Phase 1 BA/FE Study of Ensitrelvir Granules (COVID-19)

Contact for Scientific Queries	Name	Gomez - Juan Carlos
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp
Contact for Public Queries	Name	Corporate Communications Department - -
	Affiliation	Shionogi & Co., Ltd.
	Address	1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka
	Telephone	+81-6-6209-7885
	E-mail	shionogiclintrials-admin@shionogi.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 16, 2024
Actual date of first enrollment		Dec. 16, 2024
Target sample size		28
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Apparently healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and 12-lead ECG. A person with Japanese parents Participant must be 18 to 55 years of age inclusive, at the time of signing the ICF. BMI >= 18.5 and 30.0 <= Male and female
	Exclusion Criteria	Presence or History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that may significantly alter the absorption, metabolism, or elimination of drugs; determined to constitute a risk when administering the study intervention or to interfere with the interpretation of data. Participants whose systolic blood pressure is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg, or pulse rate is outside the range of 50 to 100 bpm at rest at screening or on admission (day -1) and who are considered ineligible for the study by the investigator. Any of the following abnormalities at screening or on admission (day -1): - Total bilirubin: > 1.5 x upper limit of normal (ULN) based on the facility criteria - Alanine aminotransferase (ALT): > 1.5 x ULN based on the facility criteria - Aspartate aminotransferase (AST): > 1.5 x ULN based on the facility criteria - Creatinine clearance (CLcr) (Cockcroft-Gault formula): < 90 mL/min
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		COVID-19
Intervention(s)		Oral administration of ensitrelvir
Primary Outcome(s)		Pharmacokinetics parameters

Primary Sponsor	Shionogi & Co., Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	HOUEIKAI Institutional Review Board
Address	3-28-3 Ikebukuro, Toshima-ku, Tokyo
Telephone	+81-3-5396-4530
E-Mail	kanai_shinichiro@seri.co.jp
Approval Status	Approval
Date of approval	Dec. 13, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none