A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers (ARC-28)

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

The primary purpose of this study is to compare the single-dose pharmacokinetics (PK) of AB521 tablet versus the AB521 capsule, and to evaluate the effect of food on the single-dose PK of AB521 tablet in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: AB521

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AB521 - Sequence ABC; Participants will sequentially receive AB521 capsules fasted (Treatment A), followed by AB521 tablets fasted (Treatment B), followed by AB521 tablets fed (Treatment C)	Drug: AB521; Administered as specified in the treatment arm
Experimental: AB521 - Sequence BCA; Participants will sequentially receive Treatment B, followed by Treatment C, then Treatment A	Drug: AB521; Administered as specified in the treatment arm
Experimental: AB521 - Sequence CAB; Participants will sequentially receive Treatment C, followed by Treatment A, then Treatment B	Drug: AB521; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Drug Concentration-Time Curve (AUC)	Predose, Up to 168 hours postdose
Maximum Concentration (Cmax)	Predose, Up to 168 hours postdose
Time to Maximum Concentration (Tmax)	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
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)	Predose, Up to 168 hours postdose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events	Up to 10 weeks

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: AB521
• Other Study ID Numbers: ARC-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No