deltatrials
Completed PHASE1 INTERVENTIONAL 2-arm NCT03968848

Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite

A Phase 1, Open-Label, Single-Dose Study to Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite (ACP-5862)

Sponsor: Acerta Pharma BV

Interventions acalabrutinib
Updated 7 times since 2019 Last updated: Aug 16, 2021 Started: Nov 12, 2018 Primary completion: Mar 13, 2019 Completion: Mar 29, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1 clinical study on Healthy Subjects and Hepatic Impairment, this trial is completed. The trial is conducted by Acerta Pharma BV and has accumulated 7 data snapshots since 2018. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshotCompleted~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotCompleted~Oct 2021 – ~Dec 2022 · 14 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  3. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE1

  4. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE1

  5. Oct 2021 — Dec 2022 [monthly]

    Completed PHASE1

Show 2 earlier versions
  1. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE1

  2. Jun 2019 — Jan 2021 [monthly]

    Completed PHASE1

    First recorded

Nov 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Acerta Pharma BV
  • AstraZeneca
Data source: Acerta Pharma BV

For direct contact, visit the study record on ClinicalTrials.gov .