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

Shionogi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: S-337395; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06270511

2222T1412

Details and patient eligibility

About

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

Full description

This single-center study comprises an open-label, randomized, crossover study, and a double-blinded, placebo-controlled, randomized, multiple-dose study to examine the relative bioavailability, food effect, pharmacokinetics, safety, and tolerability of different formulations of S-337395.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Part A: Open Label

Experimental group

Description:

Participants will receive different formulations of S-337395 without food and with food.

Treatment:

Drug: S-337395

Part B: Double Blind

Experimental group

Description:

Participants will receive S-337395 or placebo.

Treatment:

Drug: Placebo

Drug: S-337395