Status:
COMPLETED
A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
Lead Sponsor:
Arcus Biosciences, Inc.
Conditions:
Healthy Participants
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of casdatifan tablet versus the casdatifan capsule, and to evaluate the effect of food on the single-dose PK of ca...
Eligibility Criteria
Inclusion
- Key
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on volunteer self-reporting
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilogram (kg)/square meter (m\^2) at the screening visit, with body weight ≥ 45 kg
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs, as deemed by the study physician
- Able to swallow multiple capsules and tablets
- Has adequate peripheral venous access
- Key
Exclusion
- Has active neoplastic disease or history of neoplastic disease within 5 years of the screening visit (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
- Has abnormal liver enzyme test results or hematology values at the time of enrollment
- Has a history of additional risk factors for Torsades de pointes (example: heart failure, hypokalemia, family history of Long QT Syndrome)
- Malabsorption condition that would alter the absorption of orally administered medications at the discretion of the study physician
- Participation in another clinical study within 90 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 90-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05999513
Start Date
August 21 2023
End Date
October 31 2023
Last Update
October 17 2024
Active Locations (1)
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1
Celerion, Inc.
Lincoln, Nebraska, United States, 68502