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

JRCT ID: jRCT2071240030

Registered date:05/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pompe disease
• Date of first enrollment: 04/07/2024
• Target sample size: 15
• 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• 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