A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
NCT ID: NCT06734208
Last Updated: 2025-12-04
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
31 participants
INTERVENTIONAL
2025-01-31
2025-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
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 cohort.
Cohort 2
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 cohort.
Cohort 3
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 cohort.
Cohort 4
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 cohort.
Interventions
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Divarasib
Divarasib will be administered as a single oral dose as specified for the respective cohort.
Eligibility Criteria
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Inclusion Criteria
* Within body mass index (BMI) range of 18.0 to 45.0 kg/m2
Participants with Hepatic Impairment
* Considered to have mild, moderate, or severe hepatic impairment by Child-Pugh Score classification and has been clinically stable for at least 1 month prior to Screening
* Chronic (\>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period
Exclusion Criteria
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
Participants with Hepatic Impairment
* Have a QTcF \>480 msec for males and \>490 msec for females at Screening or Check-in. If any parameter is out of range, the ECG may be repeated for confirmation
* Any evidence of progressive liver disease that has worsened or is worsening, as determined by the investigator, within 1 month prior to Screening
* Demonstrated evidence of hepatorenal syndrome
* Ascites requiring paracentesis or other intervention up to 3 days prior to the study
* Hepatic encephalopathy Grade 2 or above
18 Years
80 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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Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States
Panax Clinical Research, LLC
Miami Lakes, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
American Research Corporation Inc.
San Antonio, Texas, United States
Countries
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Other Identifiers
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GP45713
Identifier Type: -
Identifier Source: org_study_id
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