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

• Status: Completed
• Trial end date: 2021-11-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arcus Biosciences, Inc.
• Treatments: Itraconazole

Criteria

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.