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

Arcus Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: Etrumadenant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05277012

ARC-23

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 3 patient groups

Treatment sequence ABC

Experimental group

Description:

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.

Treatment:

Drug: Etrumadenant

Treatment sequence BCA

Experimental group

Description:

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

Treatment:

Drug: Etrumadenant

Treatment sequence CAB

Experimental group

Description:

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