A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Drug-Drug Interaction of S-606001 following Multiple Oral Doses

JRCT ID: jRCT2071240106

Registered date:06/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pompe disease
• Date of first enrollment: 10/02/2025
• Target sample size: 33
• Study type: Interventional
• Intervention(s): Multiple oral administratoin of S-606001 or placebo

Outcome(s)

• Primary Outcome: Adverse events, laboratory tests (hematology, blood chemistry, coagulation, and urinalysis), vital signs (systolic/diastolic blood pressure, pulse rate, respiratory rate, and body temperature), 12-lead ECG, Holter ECG

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: Gomez Juan Carlos