A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

The aim of this study is to investigate different formulations of S-337395.

Key facts

Study ID

NCT06270511

Run by

Shionogi

People needed

50

Starts

2024-03-13

Expected to finish

2024-06-19

Last updated by the study team

2024-07-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• Body mass index within the range of 18.5 to approximately 30.0 kilograms/meter squared (inclusive) at screening.
• Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies.

You may not qualify if…

• History or presence of 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 the investigational intervention; or interfering with the interpretation of data.
• Lymphoma, leukemia, or any malignancy in the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
• Breast cancer within the past 10 years.
• Known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• Sensitivity to S-337395, or any components of the formulation, or drug or other allergy, that in the opinion of the investigator, contraindicates participation in the study.
• Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it is running

• ICON Lenexa — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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