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

2301N1113

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

2023-11-15

2023-12-08

2024-02-14

Completed

Early phase I

14

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/Exclusion criteria may apply.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 14, 'type': 'ACTUAL'}}

2024-02-29