Healthy ParticipantsPhase 1NCT07751250
Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
A Phase 1 study testing Casdatifan in people with Healthy Participants and Hepatic Impairment, run by Arcus Biosciences, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Hepatic Impairment
- What is being tested?
- Casdatifan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2026to May 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- Male participants must be vasectomized
- BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.
- Participants with Moderate HI (Group 1)
- Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.
- Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening
- Healthy Participants:
- Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
Who cannot join
- All Participants:
- Participants with Gilbert's syndrome.
- Participants with Moderate HI (Group 1):
- Positive for HBsAg or HCV Ab, and detectable viral load at screening.
- Severe complications of liver disease within the preceding 3 months of screening.
- Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.
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- Healthy Control Participants:
- History or presence of clinically significant medical or psychiatric condition or disease, or presence 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
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Research Site
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants with normal hepatic function.
- Conditions
- Healthy Participants, Hepatic Impairment
- Being tested
- Casdatifan
- Keywords
- Casdatifan, AB521, HIF-2α, Pharmacokinetics, Hepatic Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CasdatifanDrug
Participants will receive a 100 mg single oral dose of casdatifan.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental | Administered as specified in the treatment arm. Receives: Drug: Casdatifan |
| Group 2: Healthy Control Participants | Experimental | Administered as specified in the treatment arm. Receives: Drug: Casdatifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
Measured: Up to 10 days post-dose
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
Measured: Up to 10 days post-dose
Maximum observed concentration of casdatifan in plasma (Cmax)
Measured: Up to 10 days post-dose
Secondary outcomes (8)
Time to reach Cmax of casdatifan in plasma (Tmax)
Measured: Up to 10 days post-dose
Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel)
Measured: Up to 10 days post-dose
Percent of AUC0-inf extrapolated (AUC%extrap)
Measured: Up to 10 days post-dose
Apparent first order terminal elimination half life (t½)
Measured: Up to 10 days post-dose
Apparent total clearance (CL/F)
Measured: Up to 10 days post-dose
Apparent total clearance (Vz/F)
Measured: Up to 10 days post-dose
Unbound fraction (fu) of casdatifan
Measured: Up to 10 days post-dose
Number of participants experiencing Adverse Events (AEs)
Measured: Up to 23 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start14 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcus Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Arcus Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07751250
- Sponsor's protocol ID
- ARC-521-101
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website. URL: https://trials.arcusbio.com/our-transparency-policy