Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
- Registration Number
- NCT06106334
- Lead Sponsor
- Shionogi
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description S-309309 S309309 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 \[co-administration with S-309309 in the fasted state\]) S-309309 Itraconazole 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 \[co-administration with S-309309 in the fasted state\])
- Primary Outcome Measures
Name Time Method 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 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 Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309 Up to 2 weeks postdose on Days 1, 19
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Up to 5 weeks
Trial Locations
- Locations (1)
Fortrea Clinical Research Unit Inc.
🇺🇸Dallas, Texas, United States