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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: S-337395; Drug: Placebo

• Registration Number: NCT06270511
• Lead Sponsor: Shionogi

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.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-21
• Study Start: 2024-03-13
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B: Double Blind	Placebo	Participants will receive S-337395 or placebo.
Part A: Open Label	S-337395	Participants will receive different formulations of S-337395 without food and with food.
Part B: Double Blind	S-337395	Participants will receive S-337395 or placebo.

Primary Outcome Measures

Name	Time	Method
Part B: Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 21
Part A: Plasma Concentration of S-337395	Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)

Secondary Outcome Measures

Name	Time	Method
Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)	Venous: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose); Capillary: Days 1, 2, 8, and 9 (Up to 24 hours post dose)
Part A: Number of Participants Experiencing Treatment-emergent Adverse Events	Day 1 through Day 29
Part B: Plasma Concentration of S-337395	Days 1-12 (Predose, up to 96 hours post dose)

Trial Locations

Locations (1)

ICON Lenexa; 🇺🇸 Lenexa, Kansas, United States