Clinical trial NCT06270511: A Study to Investigate Different Formulations of S-337395 in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: S-337395
Bioavailability
Pharmacokinetics
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part A: Plasma Concentration of S-337395
timeFrame: Days 1-5, 8-12, and 15-19 (Predose, up to 96 hours post dose)
measure: Part B: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 21
Secondary outcomes:
measure: Part A: Number of Participants Experiencing Treatment-emergent Adverse Events
timeFrame: Day 1 through Day 29
measure: Part A: Plasma Concentration of S-337395 (Venous Samples Versus Capillary Microsamples)
timeFrame: 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)
measure: Part B: Plasma Concentration of S-337395
timeFrame: Days 1-12 (Predose, up to 96 hours post dose)
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
Study officials:
References: