NCT07751250 Comparative PK Assessment Study of Casdatifan in Moderate Hepatically Impaired Participants Versus Matched Participants With Normal Hepatic Function
| NCT ID | NCT07751250 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Arcus Biosciences, Inc. |
| Condition | Healthy Participants |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-08-14 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2026-08-14 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Arcus Biosciences
Frequently Asked Questions
Who can join the NCT07751250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 84 Years, studying Healthy Participants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07751250 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07751250 currently recruiting?
Yes, NCT07751250 is actively recruiting participants. Contact the research team at ClinicalTrialInquiry@arcusbio.com for enrollment information.
Where is the NCT07751250 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT07751250 clinical trial?
NCT07751250 is sponsored by Arcus Biosciences, Inc.. The principal investigator is Medical Director at Arcus Biosciences. The trial plans to enroll 16 participants.