Casdatifan Interaction Study in Healthy Subjects

Overseen By Arcus Biosciences

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Arcus Biosciences, Inc.

Disqualifiers: Asthma, COPD, Significant psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of casdatifan in healthy adults and to assess the effects of multiple doses of phenytoin (a strong CYP3A4 inducer) on single dose PK of casdatifan in healthy adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves assessing drug interactions, it's possible that changes to your medication regimen might be required. Please consult with the study team for specific guidance.

What makes the drug Casdatifan unique compared to other treatments?

Casdatifan is unique because it focuses on drug interactions, particularly with food and other substances, which can vary greatly among individuals. This approach is different from many treatments that do not specifically address these interactions, making it potentially safer for people who are more susceptible to side effects from such interactions. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Arcus Biosciences

Eligibility Criteria

This trial is for healthy adults who can participate in a study to understand how casdatifan, a drug under investigation, interacts with other medications. Specific eligibility criteria are not provided.

Inclusion Criteria

I am a male and have had a vasectomy.

I haven't smoked or used nicotine products for over 3 months.

My BMI is between 18 and 32, and I weigh at least 45 kg.

Exclusion Criteria

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

I have a significant health or mental condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive casdatifan with itraconazole and phenytoin to assess drug-drug interactions

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Casdatifan

Trial Overview The study is testing the interactions between casdatifan and two other drugs: itraconazole, which inhibits certain enzymes, and phenytoin, which induces them. The goal is to see how these drugs affect the presence of casdatifan in the body when taken together.

Participant Groups

Group I: Casdatifan-Itraconazole-Phenytoin Experimental Treatment 3 Interventions

Participants will receive casdatifan, itraconazole, and phenytoin.

Who Is Running the Clinical Trial?

Arcus Biosciences, Inc.

Lead Sponsor

Trials

44

Recruited

7,500+

References

1. Italy pubmed.ncbi.nlm.nih.gov

[Drug/food interactions: an actual therapeutic outcome]. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Relative prevalence of 10 types of pharmacodynamic interactions in psychiatric treatment. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Gender differences, polypharmacy, and potential pharmacological interactions in the elderly. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Drug-Drug Interactions: Research Methods and Applications. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

In vitro CYP450 enzyme down-regulation by GLP-1/glucagon co-agonist does not translate to observed drug-drug interactions in the clinic. [2022]