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OpenTrials
Completed

NCT Number: NCT06106334

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

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

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

S309309

Drug

Administered as oral capsules

Itraconazole

Drug

Administered as oral capsules

Primary outcomes

  1. Area Under the Concentration-Time Curve Extrapolated From Time 0 to Infinity (AUC0-inf) After Administration of S-309309

    Time frame: Up to 2 weeks postdose on Days 1, 19

  2. 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

    Time frame: Up to 2 weeks postdose on Days 1, 19

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

    Time frame: Up to 2 weeks postdose on Days 1, 19

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 5 weeks

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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