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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07751250
- Acronym / sponsor ID
- ARC-521-101
- Conditions
- Healthy Participants, Hepatic Impairment
- Keywords
- Casdatifan, AB521, HIF-2α, Pharmacokinetics, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Arcus Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental | Drug: CasdatifanAdministered as specified in the treatment arm. |
| Group 2: Healthy Control Participants | Experimental | Drug: CasdatifanAdministered as specified in the treatment arm. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- Participants with Gilbert's syndrome.
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CasdatifanParticipants will receive a 100 mg single oral dose of casdatifan. | Drug | Group 1: Moderate Hepatic Impairment, Group 2: Healthy Control Participants |
Primary outcome
Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
Time frame: Up to 10 days post-dose
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
Time frame: Up to 10 days post-dose
Maximum observed concentration of casdatifan in plasma (Cmax)
Time frame: Up to 10 days post-dose
8 secondary outcomes
Time to reach Cmax of casdatifan in plasma (Tmax)
Time frame: 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)
Time frame: Up to 10 days post-dose
Percent of AUC0-inf extrapolated (AUC%extrap)
Time frame: Up to 10 days post-dose
Apparent first order terminal elimination half life (t½)
Time frame: Up to 10 days post-dose
Apparent total clearance (CL/F)
Time frame: Up to 10 days post-dose
Apparent total clearance (Vz/F)
Time frame: Up to 10 days post-dose
Unbound fraction (fu) of casdatifan
Time frame: Up to 10 days post-dose
Number of participants experiencing Adverse Events (AEs)
Time frame: Up to 23 days post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Arcus Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Director (+1-510-462-3330, ClinicalTrialInquiry@arcusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t) (time frame: Up to 10 days post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.