A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants

Arcus Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Etrumadenant; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05154136

ARC-18

Details and patient eligibility

About

This study will evaluate the effect of multiple oral doses of itraconazole, on the pharmacokinetics of etrumadenant when etrumadenant is administered as a single dose in healthy adult participants.

Enrollment: 20 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, adult, male or female (of non-childbearing potential), at the screening visit
• Body mass index between 18 and 32 kilograms/m^2 inclusive, at screening
• Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
• 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 >3 months prior to the first dosing) based on participant self-reporting

Exclusion criteria

• Participants who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, rheumatological, endocrine, connective tissue diseases or disorders
• Have a clinically relevant surgical history in the opinion of the principal investigator or designee
• Have a history of relevant atopy or hypersensitivity to the study drugs or related compounds (e.g., allergy to itraconazole or other azole antifungals
• History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing

Note: This is not an exhaustive list of criterias.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Etrumadenant then Etrumadenant + Itraconazole

Experimental group

Description:

Participants will receive the Treatment A (etrumadenant) followed by Treatment B (etrumadenant + itraconazole). A washout period of 5 days will be maintained between the two treatments.

Treatment:

Drug: Itraconazole

Drug: Etrumadenant