A Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetic Profile of Etrumadenant in Healthy Adult Participants
NCT ID: NCT05154136
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2021-10-20
2021-12-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Etrumadenant then Etrumadenant + Itraconazole
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.
Etrumadenant
Capsule
Itraconazole
Capsule
Interventions
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Etrumadenant
Capsule
Itraconazole
Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
19 Years
55 Years
ALL
Yes
Sponsors
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Arcus Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Arcus Biosciences, Inc.
Locations
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Celerion
Lincoln, Nebraska, United States
Countries
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Other Identifiers
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ARC-18
Identifier Type: -
Identifier Source: org_study_id
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