NCT07641881
A Bioequivalence Study Between Two Casdatifan Tablet Strengths and Food Effect Study of Casdatifan in Healthy Adult Participants
Recruiting
PHASE1Ages 18–55InterventionalBasic scienceArcus Biosciences, Inc.
~24 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Casdatifan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum observed concentration for casdatifan
Measured over Up to 168 hours post each dose
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesArizona1
Study leadership
- Medical Director · STUDY_DIRECTOR · Arcus Biosciences
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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.
Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, standard vital signs, and ECGs, as deemed by the PI or designee.
Able to swallow multiple tablets.
Has adequate peripheral venous access.
Exclusion
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 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 of asthma or chronic obstructive pulmonary disease (including childhood), clinically significant food allergies or anaphylaxis, as deemed by PI or designee.
Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of asymptomatic gallstones).
Seizure (excluding simple febrile seizure), epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions which the PI or designee considers to be clinically significant.
What this trial measures
- Maximum observed concentration for casdatifanUp to 168 hours post each dose
- Area under the concentration-time curve for casdatifanUp to 168 hours post each dose