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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06106334
• Other study ID #: 2301N1113
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2023
• Est. completion date: February 14, 2024

Study information

• Verified date: February 2024
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 14, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Obesity

Intervention

Drug:
• S309309
Administered as oral capsules
• Itraconazole
Administered as oral capsules

Locations

Country	Name	City	State
United States	Fortrea Clinical Research Unit Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309		Up to 2 weeks postdose on Days 1, 19
Secondary	Number of Participants With Adverse Events (AEs)		Up to 5 weeks