Skip to main content
OpenTrials
Completed

NCT Number: NCT05277012

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Etrumadenant

Drug

Etrumadenant capsule and tablet formulations

Other names: AB928

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Etrumadenant

    Time frame: 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

  2. Area Under the Plasma Concentration-time Curve From 0 to Last Observed Non-zero Concentration [AUC(0-t)] of Etrumadenant

    Time frame: 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

  3. Area Under the Plasma Concentration Time Curve From Time '0' Extrapolated to Infinity [AUC(0-inf)] of Etrumadenant

    Time frame: 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

  4. Time to Cmax (Tmax) of Etrumadenant

    Time frame: 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

  5. Apparent First-order Terminal Elimination Rate Constant (Kel) of Etrumadenant

    Time frame: 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

  6. Percentage of AUC(0-inf) Extrapolation (AUC%extrap) of Etrumadenant

    Time frame: 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

  7. Apparent First Order Terminal Elimination Half-life (t1/2) of Etrumadenant

    Time frame: 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

  8. Apparent Total Plasma Clearance (CL/F) of Etrumadenant

    Time frame: 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

  9. Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Etrumadenant

    Time frame: 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

  10. Ratio of Etrumadenant metabolites to Etrumadenant

    Time frame: 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

  11. Ratio of Etrumadenant metabolites to Total Metabolite Concentration

    Time frame: 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)

    Time frame: Up to 4 months

    Safety will be assessed by monitoring adverse events and clinically significant changes in 12 lead Electrocardiogram, vital signs, and clinical laboratory tests results.

Sponsors and collaborators

Lead sponsor

Arcus Biosciences, Inc.

Industry

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.