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Liver health and drug processing: a closer look at casdatifan

NCT ID NCT07751250

Knowledge-focused Sponsor: Arcus Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This study is testing how the body processes a single dose of casdatifan, an experimental drug, in people with moderate liver impairment compared to healthy volunteers. The goal is to see if liver function changes how the drug is absorbed and cleared from the body. Participants receive one 100 mg oral dose, and researchers measure drug levels in the blood over time. This information could help guide future dosing recommendations for patients with liver issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
casdatifan (AB521)
What this could lead to
If successful, this study could help determine the right dosing of casdatifan for people with liver problems, potentially making the drug safer and more effective for them.
What could go wrong
This is a small, early-stage study focused on drug processing, not on treating a disease. Results may not reflect real-world outcomes, and the drug could still have side effects or interact unpredictably with liver function.
Why investors are watching

Arcus Biosciences is running a small phase 1 study to see how the body handles its drug casdatifan in people with moderate liver problems compared to healthy people. For a small company, this readout matters because it will show whether liver impairment changes drug levels, which affects dosing guidance for future patients and the drug's development path.

If it works: If the study shows casdatifan is safe and behaves predictably in people with liver impairment, Arcus can move forward with clearer dosing instructions for a broader patient group. That result would support the drug's continued clinical development.

If it fails: If the study finds that liver impairment causes unsafe drug levels or unexpected side effects, Arcus may need to restrict use or adjust dosing, which could delay the program. Early-stage trials often fail or reveal problems, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 84 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy participants Hepatic impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Research Site

    RECRUITING

    San Antonio, Texas, 78215, United States

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Other studies related to the condition(s) this trial covers.