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

Shionogi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Obesity

Treatments: Drug: Itraconazole; Drug: S309309

Study type: Interventional

Funder types: Industry

Identifiers

NCT06106334

2301N1113

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 1 patient group

S-309309

Experimental group

Description:

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 \[co-administration with S-309309 in the fasted state\])

Treatment:

Drug: S309309

Drug: Itraconazole