Assessing how itraconazole and phenytoin affect casdatifan in healthy adults
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of Casdatifan With Itraconazole (Strong CYP3A4 Inhibitor) and Phenytoin (Strong CYP3A4 Inducer) in Healthy Adult Participants
This study is testing how two medications, itraconazole and phenytoin, affect the way a new drug called casdatifan is processed in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Arcus Biosciences, Inc. Industry-sponsored |
| Locations | 1 site (Tempe, Arizona) |
| Trial ID | NCT06919991 on ClinicalTrials.gov |
What this trial studies
This study evaluates the pharmacokinetics of casdatifan, a drug being tested for its effects on hypoxia-inducible factor 2 alpha, in healthy adult participants. It specifically examines how multiple doses of itraconazole, a strong CYP3A4 inhibitor, and phenytoin, a strong CYP3A4 inducer, influence the drug's absorption and metabolism. The study aims to provide insights into potential drug-drug interactions that could affect the safety and efficacy of casdatifan. Participants will be closely monitored to ensure their health and safety throughout the study.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-55 who meet specific health criteria and can comply with study requirements.
Not a fit: Patients with significant medical or psychiatric conditions or those who do not meet the health criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of drug interactions involving casdatifan, leading to safer and more effective treatment protocols.
How similar studies have performed: While this study focuses on a specific drug interaction, similar studies have shown success in understanding pharmacokinetics and drug interactions, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy, adult, male or female 18-55 years of age, inclusive, at the screening visit. * Male participants must be vasectomized * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting. * BMI ≥ 18.0 and ≤ 32.0 kg/m2 and body weight ≥ 45 kg, at the screening visit * Able to swallow multiple tablets and/or capsules. Exclusion Criteria: * Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. * History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study. * History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds. * History of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Tempe, Arizona
- Celerion — Tempe, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Arcus Biosciences
- Email: ClinicalTrialInquiry@arcusbio.com
- Phone: +1-510-462-3330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.