臨床研究等提出・公開システム

Date of registration	July. 05, 2024
Last modified on	Jan. 27, 2025
Trial ID	jRCT2071240030

Scientific Title	A Phase 1, crossover, open-label study to compare the bioavailability of S-606001 between capsules and tablets and to investigate the food effect with the tablets following a single oral dose in healthy adults aged 18 to 55 years
Public Title	A phase 1 study of S-606001 tablets to assess the bioavailability and the food effect

Contact for Scientific Queries	Name	Juan Carlos Gomez
	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	Not Recruiting

Anticipated date of first enrollment		July. 04, 2024
Actual date of first enrollment		July. 04, 2024
Target sample size		23
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Individuals between ages of 18 and 55 years (inclusive) at the time of signing informed consent. -Individuals must be in good health, as determined by a medical history, physical examination, clinical laboratory evaluations, electrocardiogram (ECG). - Individuals who weigh 40 kg or more with body mass index (BMI) between 18.5 and 30.0 (inclusive). -Male or female individuals.
	Exclusion Criteria	-Individuals with a history of any cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking S-606001; or interfering with the interpretation of data. -Individuals with a history of syncope of unknown cause, sick sinus syndrome, second or third degree atrioventricular block, myocardial infarction, pulmonary congestion, arrhythmia, angina pectoris, QT interval prolonged, or conduction abnormality. -Individuals with a history of risk factors for Torsade de Pointes (eg, cardiac failure, cardiomyopathy, hypokalemia, family history of long QT syndrome, Brugada syndrome) -Individuals with a history of any gastrointestinal surgery (eg, gastric and intestinal resections) excluding appendectomy. -Individuals with or with a chronic history of liver disease. -Individuals with known abnormalities of the liver or bile ducts, excluding Gilbert's syndrome or asymptomatic gallstones.
	Age Minimum	18age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pompe disease
Intervention(s)		Oral administration of S-606001
Primary Outcome(s)		Pharmacokinetic evaluation (eg, plasma concentration, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z)

Primary Sponsor	Shionogi & Co., Ltd.

Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	June. 21, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 27, 2025	(this page)	Changes
2	Nov. 20, 2024	Detail	Changes
1	July. 05, 2024	Detail

List of change history