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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 4, 2026 → Nov 16, 2026
See other at-risk trials from Roche/Genentech

Record History

  1. Primary completion pushed from Sep 4, 2026 to Nov 16, 2026 Completion pushed from Sep 6, 2026 to Nov 16, 2026 · Eligibility criteria expanded, about 26 words Show 2 more changesShow less
    • Completion pushed from Sep 6, 2026 to Nov 16, 2026
    • Eligibility criteria expanded, about 26 words
  2. 3 versions Re-verified since Jul 2, 2026, no change to tracked fieldsv13-v15
  3. Primary completion date: Sep 5, 2026 to Sep 4, 2026 Completion date: Sep 9, 2026 to Sep 6, 2026v12 Show 1 more changeShow less
    • Completion date: Sep 9, 2026 to Sep 6, 2026
  4. 3 versions Re-verified since Mar 11, 2026, no change to tracked fieldsv9-v11
  5. Primary completion date: Sep 6, 2026 to Sep 5, 2026 Completion date: Sep 6, 2026 to Sep 9, 2026v8 Show 1 more changeShow less
    • Completion date: Sep 6, 2026 to Sep 9, 2026
Show 6 earlier versionsHide 6 earlier versions
  1. 5 versions Re-verified since Oct 15, 2025, no change to tracked fieldsv3-v7
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Aug 25, 2025 to Aug 21, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Aug 25, 2025 to Aug 21, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Roche/Genentech
366 trials monitored
See 33 trials at risk
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.
Trial Details
NCT Number NCT07144111
Lead Sponsor Genentech, Inc.
Conditions Hepatic Impairment
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov