Pompe disease
Conditions
Interventions
Oral administration of S-606001
Sponsors
Juan Carlos Gomez
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic evaluation (eg, plasma concentration, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z) | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed