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NCT03561298 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects

A Phase 1 study, sponsored by BeiGene.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT03561298: Completed Phase 1 study, sponsored by BeiGene.

NCT03561298 is a Phase 1 study that has completed, run by BeiGene. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03561298, a Phase 1 study, has completed, sponsored by BeiGene.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects

Primary Outcome

AUC from time 0 to the last quantifiable concentration (AUC0-t)

Interventions

  • DRUG BGB-3111 and Drug Cocktail

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2018-06-07
Est. Completion 2018-07-02
Phase Phase 1
BeiGene

65 total trials

What the finished NCT03561298 record still lists

NCT03561298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 1 intervention - of which BGB-3111 and Drug Cocktail is the first listed.

NCT03561298 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03561298 about?

NCT03561298 is a clinical study titled "A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy Subjects". This study is designed to evaluate the safety and pharmacokinetic interaction of effects of multiple doses of zanubrutinib with a "Cocktail" of five probe drugs for cytochrome P450 (CYP) 3A, CYP2C9, CYP2C19, P-glycoprotein and breast cancer resistance protein (BCRP) in healthy subjects

What is the current status of trial NCT03561298?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2018-06-07. Estimated completion is 2018-07-02.

What interventions are being tested in trial NCT03561298?

The interventions under investigation include: BGB-3111 and Drug Cocktail (DRUG).

Who is sponsoring clinical trial NCT03561298?

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

How this trial's enrollment target compares

Where NCT03561298's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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 NCT03561298, the US trial registry maintained by the National Library of Medicine. NCT03561298 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.