A Relative Bioavailability Study and Food Effect Study of AB521 in Healthy Adult Volunteers

Healthy Participants Clinical Trial

— ARC-28  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05999513
• Other study ID #: ARC-28
• Status: Completed
• Phase: Phase 1
• Start date: August 21, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: May 2024
• Source: Arcus Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• AB521
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Celerion, Inc.	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Plasma Drug Concentration-Time Curve (AUC)		Predose, Up to 168 hours postdose
Primary	Maximum Concentration (Cmax)		Predose, Up to 168 hours postdose
Primary	Time to Maximum Concentration (Tmax)		Predose, Up to 168 hours postdose
Primary	Terminal Half-Life Time (t1/2)		Predose, Up to 168 hours postdose
Primary	Apparent Total Plasma Clearance (CL/F)		Predose, Up to 168 hours postdose
Primary	Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)		Predose, Up to 168 hours postdose
Secondary	Number of Participants With Adverse Events		Up to 10 weeks