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

NCT05277012 | Completed Phase 1 FDA Drug

• 1 other identifier: ARC-23
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Etrumadenant; Healthy participants; Pharmacokinetics; AB928; Tablet; Capsule

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Up to 4 months

Study Arms (3)

Treatment sequence ABC

EXPERIMENTAL

Participants will be sequentially administered with Treatment A, B then C (Treatment A: etrumadenant capsule in fasted state; Treatment B: etrumadenant tablet in fasted state; Treatment C: etrumadenant tablet in fed state). Each treatment will be separated by a washout period of 7 days.

Drug: Etrumadenant

Treatment sequence BCA

EXPERIMENTAL

Participants will be sequentially administered with Treatment B, C then A. Each treatment will be separated by a washout period of 7 days.

Drug: Etrumadenant

Treatment sequence CAB

EXPERIMENTAL

Participants will be sequentially administered with Treatment C, A then B. Each treatment will be separated by a washout period of 7 days.

Drug: Etrumadenant

Interventions

Etrumadenant DRUG

Etrumadenant capsule and tablet formulations

Also known as: AB928

Treatment sequence ABC; Treatment sequence BCA; Treatment sequence CAB

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arcus Biosciences, Inc.: lead
• Gilead Sciences: collaborator

Study Sites (1)

Investigational Site

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Medical Director

  Arcus Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study participants will receive 3 treatments (Treatment A, B and C) sequentially during the Treatment Period 1, 2, and 3. Treatment A: etrumadenant capsule in fasted state Treatment B: etrumadenant tablet in fasted state Treatment C: etrumadenant tablet in fed state Each treatment will be separated by a washout period of 7 days.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: March 14, 2022
• Study Start: February 10, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

US (1)