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

Part of paid clinical trials in Miami, Florida.

Sponsor
Genentech, Inc.
Study ID
NCT06734208
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Divarasib — DRUG
    Divarasib will be administered as a single oral dose as specified for the respective cohort.

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Dec 2025
Primary completion
Nov 27, 2025
Completion
Nov 27, 2025

Study Design

Enrollment
31 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants will receive a single oral dose of Divarasib on Day 1.
  • Experimental: Cohort 2
    Participants will receive a single oral dose of Divarasib on Day 1.
  • Experimental: Cohort 3
    Participants will receive a single oral dose of Divarasib on Day 1.
  • Experimental: Cohort 4
    Participants will receive a single oral dose of Divarasib on Day 1.

Primary Outcome Measure

Plasma Concentration of Divarasib [ Time Frame: Day 1 to Day 7 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology of Miami, Inc.MiamiFlorida33014-
Panax Clinical Research, LLCMiami LakesFlorida33014-
Orlando Clinical Research CenterOrlandoFlorida32809-
American Research Corporation Inc.San AntonioTexas78215-

Find similar trials in Miami, FL

By research site
Clinical Pharmacology of Miami, Inc.· Miami, FLPanax Clinical Research, LLC· Miami Lakes, FLOrlando Clinical Research Center· Orlando, FLAmerican Research Corporation Inc.· San Antonio, TX

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