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

NCT ID: NCT06270511

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-13
• Study Completion Date: 2024-06-19

Brief Summary

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

Detailed 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Part A: Open Label

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

Group Type: EXPERIMENTAL

S-337395

Intervention Type: DRUG

Administered as an oral suspension.

Part B: Double Blind

Participants will receive S-337395 or placebo.

Group Type: EXPERIMENTAL

S-337395

Intervention Type: DRUG

Administered as an oral suspension.

Placebo

Intervention Type: DRUG

Administered as an oral suspension.

Interventions

S-337395

Administered as an oral suspension.

Intervention Type: DRUG

Placebo

Administered as an oral suspension.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Lenexa

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

2222T1412

Identifier Type: -

Identifier Source: org_study_id