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Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Nov 30, 2026 → Aug 31, 2027
See other at-risk trials from Biogen

Record History

  1. Primary and study completion pushed from Nov 30, 2026 to Aug 31, 2027 Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 4 of 9 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 9 entries
  2. Re-verified, no change to tracked fieldsv17
  3. Study sites: 6 to 8v16
  4. Study sites: 5 to 6v15
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Primary and study completion dates: Nov 30, 2024 to Nov 30, 2026 Study sites: 4 to 5v13 Show 1 more changeShow less
    • Study sites: 4 to 5
  2. Primary and study completion dates: Aug 1, 2024 to Nov 30, 2024v12
  3. Primary and study completion dates: Nov 30, 2023 to Aug 1, 2024v11
  4. Site details revised at 1 of 4 sitesv10
  5. Eligibility criteria shortened, about 24 wordsv9 See this version in full on ClinicalTrials.gov ↗
  6. Primary and study completion dates: Mar 31, 2024 to Nov 30, 2023v8
  7. Primary and study completion dates: Mar 31, 2023 to Mar 31, 2024 Primary endpoints revised (3) · Interventions: E7090 (Drug), E7090 (Drug) to Tasurgratinib (Drug), Tasurgratinib (Drug) · Secondary endpoints revised (9) · 1 morev7 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Interventions: E7090 (Drug), E7090 (Drug) to Tasurgratinib (Drug), Tasurgratinib (Drug)
    • Secondary endpoints revised (9)
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 3 to 4v6
  9. Lead sponsor: Eisai Inc. to Eisai Co., Ltd. Primary and study completion dates: May 31, 2022 to Mar 31, 2023v5 Show 1 more changeShow less
    • Primary and study completion dates: May 31, 2022 to Mar 31, 2023
  10. Primary and study completion dates: Apr 19, 2022 to May 31, 2022v4
  11. Primary completion date: Dec 31, 2021 to Apr 19, 2022 Completion date: Mar 31, 2022 to Apr 19, 2022 · Site details revised at 2 of 3 sitesv3 Show 2 more changesShow less
    • Completion date: Mar 31, 2022 to Apr 19, 2022
    • Site details revised at 2 of 3 sites
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date changed from estimate of Feb 19, 2020 to Feb 27, 2020v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Feb 19, 2020 to Feb 27, 2020
  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.
Biogen
92 trials monitored
See 7 trials at risk
The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.
Trial Details
NCT Number NCT04271488
Lead Sponsor Eisai Co., Ltd.
Conditions Hepatic Impairment
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov