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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how casdatifan, a new treatment, interacts with other drugs, specifically itraconazole and phenytoin, in healthy adults. Researchers seek to understand how these drugs affect the body's processing of casdatifan. Ideal candidates for this trial are healthy non-smokers who can swallow pills and do not have asthma or significant allergies. As a Phase 1 trial, this research focuses on understanding how casdatifan works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that casdatifan is generally safe and well-tolerated in people. One study found that both single and multiple doses of casdatifan were safe for healthy participants. They experienced no serious side effects, and the drug behaved as expected in the body. Although this trial is in an early stage, with the treatment still under close safety monitoring, these initial results provide some reassurance about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments that typically focus on one pathway, Casdatifan is unique because it is being explored for its interaction with other drugs like itraconazole and phenytoin. Most treatments for conditions requiring complex drug interactions don't consider these combinations upfront. However, Casdatifan's potential to work effectively alongside these medications highlights its versatility and ability to be used in multifaceted treatment plans. Researchers are excited about Casdatifan because it could lead to better personalized treatment strategies by understanding these drug interactions, potentially resulting in more efficient and safer therapies.

What evidence suggests that this trial's treatments could be effective?

Research has shown that casdatifan is safe and effective, particularly for treating clear cell renal cell carcinoma, a type of kidney cancer. In studies, many patients responded well to various doses. Casdatifan is generally safe, with most side effects being mild. It also minimally interferes with other medications, making it a suitable option alongside other treatments. Overall, casdatifan's effectiveness and safety make it a strong candidate for further research as a treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Arcus Biosciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40717339/

Pharmacokinetics, pharmacodynamics and safety of ... Conclusions: Casdatifan, after single and multiple dosing in healthy participants, was safe and tolerable. Linear PK was associated with a mean ...

2. bpspubs.onlinelibrary.wiley.com bpspubs.onlinelibrary.wiley.com/doi/10.1002/bcp.70169

Pharmacokinetics, pharmacodynamics and safety of ... In vitro casdatifan exhibited minimal drug–drug interaction (DDI) potential, as it had no effect on inhibiting major CYP enzymes in vitro, and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06919991

Drug-Drug Interaction Study of Casdatifan in Healthy Adult ... Study Overview. 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 ...

4. urologytimes.com urologytimes.com/view/casdatifan-is-linked-with-promising-safety-efficacy-in-clear-cell-rcc

Casdatifan is linked with promising safety, efficacy in clear ... TEAEs related to casdatifan were observed in 31 (94%) patients, 28 (90%) patients, and 27 (93%) patients in the 50 mg twice daily, 50 mg/day, ...

5. academic.oup.com academic.oup.com/oncolo/article/29/Supplement_1/S30/7727969

56 Clinical Pharmacokinetic/Pharmacodynamic (PK/PD ... Casdatifan showed dose-proportional increases in plasma exposure over the 3-150 mg dose range after single and multiple doses. Casdatifan PK was ...

6. ctv.veeva.com ctv.veeva.com/study/drug-drug-interaction-study-of-casdatifan-in-healthy-adult-participants-arc29

Drug-Drug Interaction Study of Casdatifan in Healthy Adult ... The purpose of the study is to assess the effects of multiple doses of itraconazole (a strong CYP3A4 inhibitor) on single dose PK of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06919991?term=AREA%5BBasicSearch%5D(Itraconazole%20AND%20CYP3A4)&rank=4

Drug-Drug Interaction Study of Casdatifan in Healthy Adult ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

8. synapse.patsnap.com synapse.patsnap.com/drug/425cd956f9054e7aba45aef2af7880d7

Casdatifan - Drug Targets, Indications, Patents Casdatifan (AB521) is a potent and selective inhibitor of HIF-2α, currently under clin. evaluation for the treatment of clear cell renal cell carcinoma (ccRCC).