NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071240030

Registered date:05/07/2024

A phase 1 study of S-606001 tablets to assess the bioavailability and the food effect

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPompe disease
Date of first enrollment04/07/2024
Target sample size15
Countries of recruitment
Study typeInterventional
Intervention(s)Oral administration of S-606001

Outcome(s)

Primary OutcomePharmacokinetic evaluation (eg, plasma concentration, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z)
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 55age old
GenderBoth
Include 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.
Exclude 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.

Related Information

Contact

Public contact
Name Corporate Communications Department
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.
Scientific contact
Name Gomez Juan Carlos
Address 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045
Telephone +81-6-6209-7885
E-mail shionogiclintrials-admin@shionogi.co.jp
Affiliation Shionogi &amp; Co., Ltd.