What is casdatifan studying in this clinical trial?

This trial is studying how casdatifan is absorbed and processed in the body when given as different tablet doses and with or without food. Researchers aim to understand how the drug’s concentration changes under these conditions. The study is sponsored by Arcus Biosciences, Inc. and involves healthy adult volunteers.

Who may be eligible for this healthy volunteer clinical trial?

Adults aged 18 to 55 years who are medically healthy and non-smokers may be eligible. Participants must have a body mass index between 18.0 and 32.0 kg/m2, weigh at least 45 kg, and be able to swallow multiple tablets. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy volunteer clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 55Years

All Genders

Healthy Volunteers

ID07641881

Study Comparing Pharmacokinetics and Food Effects of Casdatifan Tablets in Healthy Adults Aged 18 to 55

Led by Arcus Biosciences, Inc. · Updated on 2026-06-17

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This trial studies the pharmacokinetics of casdatifan in healthy adults aged 18 to 55 years. It compares the absorption and concentration levels of a single 100 mg dose given as one tablet versus four 25 mg tablets under fasting conditions. The study also evaluates how food intake affects the drugs pharmacokinetics when the 100 mg dose is taken as four tablets with food. Participants receive casdatifan in three different ways four 25 mg tablets while fasting, one 100 mg tablet while fasting, and four 25 mg tablets after a meal. This crossover design allows each participant to receive all treatments in a randomized order, enabling direct comparison of absorption and drug levels. During the study, participants are monitored for up to 168 hours after each dose to measure drug concentration and how the body processes casdatifan. Researchers assess the peak concentration, time to peak, elimination rate, and total exposure to the drug. Safety is monitored by recording any adverse events for up to 43 days. The entire study is conducted with healthy volunteers, and participation lasts until all dosing and follow-up assessments are complete.

CONDITIONS

Brief Title

A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants

Who Can Participate

Age: 18Years - 55Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Continuous non-smoker for at least 3 months before first dosing
Body mass index between 18.0 and 32.0 kg/m2 and body weight at least 45 kg at screening
Medically healthy with no significant medical history or abnormal lab/vital signs as judged by the investigator
Able to swallow multiple tablets
Adequate peripheral venous access for blood sampling

You will not qualify if you...

Mentally or legally incapacitated or significant emotional problems at screening or expected during the study
History of illness that may confound study results or pose extra risk as judged by the investigator
History of asthma, chronic obstructive pulmonary disease, serious food allergies, or anaphylaxis
Current or chronic liver disease or known hepatic/biliary abnormalities except asymptomatic gallstones
History of seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other significant neurological conditions

Research Team

Medical Director

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