A Study to Evaluate Pharmacokinetics (PK) of Etrumadenant... | NCT05277012

NCT05277012

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Gilead Sciences	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Etrumadenant	Drug	Etrumadenant capsule and tablet formulations	Treatment sequence ABC Treatment sequence BCA Treatment sequence CAB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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.

Name	Affiliation	Role
Medical Director	Arcus Biosciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Lincoln	Nebraska	68502	United States

IPD Sharing Statement Module