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

NCT06270511 | Completed Phase 1 FDA Drug

• 1 other identifier: 2222T1412
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

S-337395; Bioavailability; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Part A: Plasma Concentration of S-337395

  Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)

• Part B: Number of Participants Experiencing Treatment-emergent Adverse Events

  Day 1 through Day 21

Secondary Outcomes (3)

• Part A: Number of Participants Experiencing Treatment-emergent Adverse Events

  Day 1 through Day 29

• 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 B: Plasma Concentration of S-337395

  Days 1-12 (Predose, up to 96 hours post dose)

Study Arms (2)

Part A: Open Label

EXPERIMENTAL

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

Drug: S-337395

Part B: Double Blind

EXPERIMENTAL

Participants will receive S-337395 or placebo.

Drug: S-337395; Drug: Placebo

Interventions

S-337395 DRUG

Administered as an oral suspension.

Part A: Open Label; Part B: Double Blind

Placebo DRUG

Administered as an oral suspension.

Part B: Double Blind

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part A will be open label; Part B will be double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: March 13, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 19, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

US (1)