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

NCT06106334 | Completed Phase 1 FDA Drug

• 1 other identifier: 2301N1113
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Maximum Observed Plasma Concentration (Cmax) After Administration of S-309309

  Up to 2 weeks postdose on Days 1, 19

Secondary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  Up to 5 weeks

Study Arms (1)

S-309309

EXPERIMENTAL

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

Drug: S309309; Drug: Itraconazole

Interventions

S309309 DRUG

Administered as oral capsules

S-309309

Itraconazole DRUG

Administered as oral capsules

S-309309

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shionogi: lead

Study Sites (1)

Fortrea Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Medical Director

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 15, 2023
• Primary Completion: December 8, 2023
• Study Completion: February 14, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)