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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Obesity, Healthy Volunteers

Intervention / Treatment
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* Drug: S309309
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S-309309<br>All participants will receive each of the following treatments: Days 1 and 19: S-309309 once daily (QD); in the fasted state) Day 15: Itraconazole twice daily (BID); in the fed state) Days 16 to 24: Itraconazole QD (in the fed state, except for Day 19 [co-administration with S-309309 in the fasted state]) | Drug: S309309<br>* Administered as oral capsules<br>Drug: Itraconazole<br>* Administered as oral capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) |  | Up to 5 weeks |