A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants
NCT ID: NCT06690138
Last Updated: 2025-04-15
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
18 participants
INTERVENTIONAL
2024-11-15
2025-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Treatment A
Participants will receive a single oral dose of Divarasib on Day 1.
Divarasib
Divarasib will be administered as a single oral dose as specified for the respective period.
Treatment B
Participants will receive Itraconazole twice a day (BID) on Day 1 and once a day (QD) from Day 2 to Day 13. Participants will receive Divarasib in combination with Itraconazole on Day 5.
Divarasib
Divarasib will be administered as a single oral dose as specified for the respective period.
Itraconazole
Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period.
Interventions
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Divarasib
Divarasib will be administered as a single oral dose as specified for the respective period.
Itraconazole
Itraconazole will be administered BID on Day 1 and QD from Day 2 to 13 and as specified for the respective period.
Eligibility Criteria
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Inclusion Criteria
* Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive
Exclusion Criteria
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* Poor peripheral venous access
18 Years
60 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Dallas Clinical Research Unit
Dallas, Texas, United States
Countries
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Other Identifiers
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GP45714
Identifier Type: -
Identifier Source: org_study_id
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