A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib

Part of paid clinical trials in Lake Forest, California.

Sponsor
Genentech, Inc.
Study ID
NCT07144111
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatic Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Inavolisib — DRUG
    Participants will receive a single oral dose of inavolisib

Study Details

This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.

Key Dates

Start date
Aug 21, 2025
Status verified
Jun 2026
Primary completion
Sep 4, 2026
Completion
Sep 6, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1
  • Experimental: Cohort 2
    Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1
  • Experimental: Cohort 3
    Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1

Primary Outcome Measure

Maximum Observed Concentration (Cmax) of Inavolisib [ Time Frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose ]

Central Contacts

  • Reference Study ID Number: GP45942 https://forpatients.roche.com
    888-662-6728 (U.S. and Canada)
    [email protected]
  • Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (4)

FacilityCityStateZIPSite coordinators
Orange County Research CenterLake ForestCalifornia92630-
Orlando Clinical Research CenterOrlandoFlorida32809-
Pinnacle Clinical Research - San AntonioSan AntonioTexas78229-
The Texas Liver Institute, Inc.San AntonioTexas78215-

Find similar trials in Lake Forest, CA

By research site
Orange County Research Center· Lake Forest, CAOrlando Clinical Research Center· Orlando, FLPinnacle Clinical Research - San Antonio· San Antonio, TXThe Texas Liver Institute, Inc.· San Antonio, TX

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