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 | Recruiting |
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Health condition(s) or Problem(s) studied | Pompe disease |
Date of first enrollment | 04/07/2024 |
Target sample size | 15 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Oral administration of S-606001 |
Outcome(s)
Primary Outcome | Pharmacokinetic evaluation (eg, plasma concentration, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z) |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 55age old |
Gender | Both |
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
Primary Sponsor | Juan Carlos Gomez |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & 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 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |