A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants
Completed · Phase 1
Conditions studied: Healthy Participants
In brief
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.
Key facts
- Study ID
- NCT05154136
- Run by
- Arcus Biosciences, Inc.
- People needed
- 20
- Starts
- 2021-10-20
- Expected to finish
- 2021-12-10
- Last updated by the study team
- 2024-05-24
Who can join
Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Celerion — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.