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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, 2-Part Study to Evaluate the Relative Bioavailability of and Food-Effect on Pharmacokinetics of Different Formulations of S-337395, and to Assess the Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of S-337395 in Healthy Adult Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06270511
• Other study ID #: 2222T1412
• Status: Recruiting
• Phase: Phase 1
• Start date: March 13, 2024
• Est. completion date: June 19, 2024

Study information

• Verified date: March 2024
• Source: Shionogi Inc.
• Contact: Shionogi Clinical Trials Administrator Clinical Support Help Lin
• Phone: 1-800-849-9707
• Email: Shionogiclintrials-admin[@]shionogi.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 19, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• S-337395
Administered as an oral suspension.
• Placebo
Administered as an oral suspension.

Locations

Country	Name	City	State
United States	ICON Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Plasma Concentration of S-337395		Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
Primary	Part B: Number of Participants Experiencing Treatment-emergent Adverse Events		Day 1 through Day 21
Secondary	Part A: Number of Participants Experiencing Treatment-emergent Adverse Events		Day 1 through Day 29
Secondary	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)
Secondary	Part B: Plasma Concentration of S-337395		Days 1-12 (Predose, up to 96 hours post dose)