A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

Purpose

This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.

Condition

  • Hepatic Impairment

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Males or females of non-childbearing potential - 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

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 		Participants will receive a single oral dose of Divarasib on Day 1.
  • Drug: Divarasib
    Divarasib will be administered as a single oral dose as specified for the respective cohort.
Experimental
Cohort 2 		Participants will receive a single oral dose of Divarasib on Day 1.
  • Drug: Divarasib
    Divarasib will be administered as a single oral dose as specified for the respective cohort.
Experimental
Cohort 3 		Participants will receive a single oral dose of Divarasib on Day 1.
  • Drug: Divarasib
    Divarasib will be administered as a single oral dose as specified for the respective cohort.
Experimental
Cohort 4 		Participants will receive a single oral dose of Divarasib on Day 1.
  • Drug: Divarasib
    Divarasib will be administered as a single oral dose as specified for the respective cohort.

Recruiting Locations

Orlando Clinical Research Center
Orlando, Florida 32809

More Details

NCT ID
NCT06734208
Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GP45713 https://forpatients.roche.com/
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center