Healthy Participants
Conditions
Keywords
AB521, casdatifan
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 casdatifan tablet in healthy adult volunteers.
Interventions
DRUGcasdatifan
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Maximum Concentration (Tmax) | Predose, Up to 168 hours postdose |
| Area Under the Plasma Drug Concentration-Time Curve (AUC) | Predose, Up to 168 hours postdose |
| Maximum Concentration (Cmax) | Predose, Up to 168 hours postdose |
| Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) | Predose, Up to 168 hours postdose |
| Terminal Half-Life Time (t1/2) | Predose, Up to 168 hours postdose |
| Apparent Total Plasma Clearance (CL/F) | Predose, Up to 168 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events | Up to 10 weeks |
Countries
United States
Outcome results
None listed