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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06270511

Enrollment

Registered

2024-02-21

Start date

2024-03-13

Completion date

2024-06-19

Last updated

2024-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

S-337395, Bioavailability, Pharmacokinetics

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.

Interventions

DRUGS-337395

Administered as an oral suspension.

DRUGPlacebo

Administered as an oral suspension.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Masking description

Part A will be open label; Part B will be double blind

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026