A Study to Evaluate Pharmacokinetics (PK) of Etrumadenant Tablet and Capsule Formulations in Healthy Adult Participants

Healthy Participants Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, Single-dose, Three-treatment, Three-way Crossover Pharmacokinetic Study to Evaluate the Relative Bioavailability of Etrumadenant (AB928) Tablet and Capsule Formulations and Food Effect on the Pharmacokinetics of the Tablet Formulation in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277012
• Other study ID #: ARC-23
• Status: Completed
• Phase: Phase 1
• Start date: February 10, 2022
• Est. completion date: March 31, 2022

Study information

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

Clinical Trial Summary

This study will compare the pharmacokinetics (PK) effect of single-dose etrumadenant tablet and capsule formulations in fasted conditions. The effect of food on single-dose PK of tablet formulation will also be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy, adult, male or female (non-childbearing potential), 19-55 years of age, inclusive, at the screening visit.

• Body mass index (BMI) between 18.0 and 32.0 kilograms/m^2 inclusive, at screening.

• Healthy as determined by medical history, physical examination, vital signs, and ECG assessed at the screening visit.

• Clinical laboratory test results clinically acceptable at screening and check in.

• Non-smokers or ex-smokers [must have ceased smoking and stopped using nicotine containing products greater than (>) 3 months prior to the first dosing] based on participant self-reporting.

• Able to swallow multiple capsules or tablets.

Exclusion Criteria:

• Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, rheumatological, dermatological, endocrine, connective tissue diseases or disorders, in the opinion of the PI or designee.

• Have a clinically relevant surgical history, in the opinion of the PI or designee.

• History of relevant atopy or hypersensitivity to etrumadenant or related compounds.

• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing.

• History (within 3 months of screening visit) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 g of alcohol [equivalent to approximately 8 oz of beer (5.5% alcohol); 1 oz of 45% alcohol; or 3.5 oz of wine (12% alcohol)] based on self-reporting.

• Have a significant infection or known inflammatory process upon screening or check in, in the opinion of the PI or designee.

• Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or check in.

• Female participants of childbearing potential.

• Positive results for hepatitis B, C, HIV-1 or HIV-2.

• Clinically significant hypokalemia in the opinion of the PI or designee.

• Have been on a diet incompatible with the on study diet, in the opinion of the PI or designee, within the 30 days prior to the first dosing.

• Donation of blood or significant blood loss within 56 days prior to the first dosing.

• Plasma donation within 7 days prior to the first dosing.

• Participation in another clinical study within 30 days prior to the first dosing.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Etrumadenant
Etrumadenant capsule and tablet formulations

Locations

Country	Name	City	State
United States	Investigational Site	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Arcus Biosciences, Inc.	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Time to Cmax (Tmax) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Apparent First-order Terminal Elimination Rate Constant (Kel) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Apparent First Order Terminal Elimination Half-life (t1/2) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Apparent Total Plasma Clearance (CL/F) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Ratio of Etrumadenant metabolites to Etrumadenant		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Primary	Ratio of Etrumadenant metabolites to Total Metabolite Concentration		Multiple timepoint evaluations from pre-dose to 24 hours post-dose at Days 1, 2, 3, 4, 5, and 6 during Treatment Period 1, 2 and 3
Secondary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Safety will be assessed by monitoring adverse events and clinically significant changes in 12 lead Electrocardiogram, vital signs, and clinical laboratory tests results.	Up to 4 months