Clinical trial NCT05999513: A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers
Official title: A Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 3-Way Crossover, Pharmacokinetic Study to Evaluate the Relative Bioavailability of AB521 Tablet and Capsule Formulations and the Effect of Food on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: AB521
casdatifan
Lead sponsor: Arcus Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-21
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Plasma Drug Concentration-Time Curve (AUC)
timeFrame: Predose, Up to 168 hours postdose
measure: Maximum Concentration (Cmax)
timeFrame: Predose, Up to 168 hours postdose
measure: Time to Maximum Concentration (Tmax)
timeFrame: Predose, Up to 168 hours postdose
measure: Terminal Half-Life Time (t1/2)
timeFrame: Predose, Up to 168 hours postdose
measure: Apparent Total Plasma Clearance (CL/F)
timeFrame: Predose, Up to 168 hours postdose
measure: Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
timeFrame: Predose, Up to 168 hours postdose
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion, Inc.
state: Nebraska
Study officials:
affiliation: Arcus Biosciences
name: Medical Director
role: STUDY_DIRECTOR
References: