Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants

A Crossover, Phase 1, Open-label, One-arm Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Male and Female Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06106334

Enrollment

Registered

2023-10-30

Start date

2023-11-15

Completion date

2024-02-14

Last updated

2024-02-29

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

Conditions

Healthy Volunteers, Obesity

Brief summary

The primary purpose of this study is to determine the effect of repeated administration of itraconazole on the pharmacokinetic (PK) profile of S-309309; and the PK of S-309309 following administration of S-309309 alone and co-administration with itraconazole

Interventions

DRUGS309309

Administered as oral capsules

DRUGItraconazole

Administered as oral capsules

Study design

Allocation

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Participants who are considered to be medically healthy as determined by the investigator * Participants whose body mass index (BMI) is within the range of ≥ 18.5 to ≤ 30.0 kg/m\^2 * Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * Participants who understand the study procedures and agree to participate by providing written informed consent * Participants who are willing and able to comply with all study procedures and restrictions Key

Exclusion criteria

* Participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug. * Participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema. * Participants who have a history of gastrointestinal surgery including, but not limited to, cholecystectomy, gastric resection, and/or intestinal resection that may result in a clinically significant abnormality in gastrointestinal function (except for an appendectomy). Participants can be considered by the investigator (or sub-investigator) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations. * Participants who are considered inappropriate for participation in the study for any reason by the investigator (or sub-investigator). Note: Other protocol defined Inclusion/

Design outcomes

Primary

Measure	Time frame
Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309	Up to 2 weeks postdose on Days 1, 19
Area Under the Concentration-Time Curve Extrapolated From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) After Administration of S-309309	Up to 2 weeks postdose on Days 1, 19
Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309	Up to 2 weeks postdose on Days 1, 19

Secondary

Measure	Time frame
Number of Participants With Adverse Events (AEs)	Up to 5 weeks

Countries

United States

Outcome results

None listed

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