Status:
COMPLETED
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
Lead Sponsor:
Shionogi
Conditions:
Obesity
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06106334
Start Date
November 15 2023
End Date
February 14 2024
Last Update
February 29 2024
Active Locations (1)
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1
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States, 75247