NCT06106334CompletedPhase 1
Effect of Administration of Itraconazole on the Pharmacokinetics of S-309309 in Healthy Participants
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
Source: ClinicalTrials.gov · Last updated 29 Feb 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 24 Oct 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 8 Dec 2023
- Lead sponsor
- Shionogi
- Diseases
- Obesity
- NCT number
- NCT06106334
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 14
- From 15 Nov 2023 to the primary completion date, 8 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fortrea Clinical Research Unit Inc. Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.