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

NCT ID: NCT06106334

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-02-14

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

Conditions

Obesity; Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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])

Group Type: EXPERIMENTAL

S309309

Intervention Type: DRUG

Administered as oral capsules

Itraconazole

Intervention Type: DRUG

Administered as oral capsules

Interventions

S309309

Administered as oral capsules

Intervention Type: DRUG

Itraconazole

Administered as oral capsules

Intervention Type: DRUG

Eligibility Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shionogi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Shionogi

Locations

Fortrea Clinical Research Unit Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

2301N1113

Identifier Type: -

Identifier Source: org_study_id