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NCT03465059 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function

A Phase 1 study, sponsored by BeiGene.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT03465059: Completed Phase 1 study, sponsored by BeiGene.

NCT03465059 is a Phase 1 study that has completed, run by BeiGene. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03465059, a Phase 1 study, has completed, sponsored by BeiGene.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects

Primary Outcome

Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib

Interventions

  • DRUG Zanubrutinib

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2018-05-30
Est. Completion 2018-10-19
Phase Phase 1
BeiGene

65 total trials

What the finished NCT03465059 record still lists

NCT03465059 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

The record links to 0 conditions, and to 1 intervention - of which Zanubrutinib is the first listed.

NCT03465059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03465059 about?

NCT03465059 is a clinical study titled "Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function". This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects

What is the current status of trial NCT03465059?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2018-05-30. Estimated completion is 2018-10-19.

What interventions are being tested in trial NCT03465059?

The interventions under investigation include: Zanubrutinib (DRUG).

Who is sponsoring clinical trial NCT03465059?

This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03465059's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03465059, the US trial registry maintained by the National Library of Medicine. NCT03465059 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.