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

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Shionogi

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: S-337395
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06270511
2222T1412

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

50 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Shionogi Clinical Trials Administrator Clinical Support Help Line

Data sourced from clinicaltrials.gov

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