Clinical trial NCT06106334: Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Healthy Volunteers
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309
timeFrame: Up to 2 weeks postdose on Days 1, 19
measure: 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
timeFrame: Up to 2 weeks postdose on Days 1, 19
measure: Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309
timeFrame: Up to 2 weeks postdose on Days 1, 19
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea Clinical Research Unit Inc.
state: Texas
Study officials:
affiliation: Shionogi
name: Medical Director
role: STUDY_DIRECTOR
References: