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

NCT ID: NCT05277012

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2022-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment sequence ABC

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.

Group Type: EXPERIMENTAL

Etrumadenant

Intervention Type: DRUG

Etrumadenant capsule and tablet formulations

Treatment sequence BCA

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

Group Type: EXPERIMENTAL

Etrumadenant

Intervention Type: DRUG

Etrumadenant capsule and tablet formulations

Treatment sequence CAB

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

Group Type: EXPERIMENTAL

Etrumadenant

Intervention Type: DRUG

Etrumadenant capsule and tablet formulations

Interventions

Etrumadenant

Etrumadenant capsule and tablet formulations

Intervention Type: DRUG

Other Intervention Names

AB928

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Arcus Biosciences

Locations

Investigational Site

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

ARC-23

Identifier Type: -

Identifier Source: org_study_id