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

A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Drug-Drug Interaction of S-606001 following Multiple Oral Doses in Healthy Adult Participants Aged 18 to 55 Years

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240106

Enrollment

Registered

2025-02-06

Start date

2025-02-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pompe disease

Interventions

Multiple oral administratoin of S-606001 or placebo

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
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	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026