Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: S-309309 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
Administered as oral capsules
Drug: Itraconazole
Administered as oral capsules
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of Participants With Adverse Events (AEs) [Up to 5 weeks]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Participants who are considered to be medically healthy as determined by the investigator
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Participants whose body mass index (BMI) is within the range of ≥ 18.5 to ≤ 30.0 kg/m^2
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Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
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Participants who understand the study procedures and agree to participate by providing written informed consent
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Participants who are willing and able to comply with all study procedures and restrictions
Key Exclusion Criteria:
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Participants who have a history of clinically significant hypersensitivity or severe side effects induced by a drug.
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Participants who have a history of ventricular dysfunction, congestive heart failure, or pulmonary edema.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fortrea Clinical Research Unit Inc. | Dallas | Texas | United States | 75247 |
Sponsors and Collaborators
- Shionogi
Investigators
- Study Director: Medical Director, Shionogi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2301N1113