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NCT04768985 · ClinicalTrials.gov registry record · Phase 1

Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
66
Enrollment target

NCT04768985: Completed Phase 1 study, sponsored by AstraZeneca.

NCT04768985 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 66 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04768985, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
66 participants
Enrollment target

Study Summary

This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment A) compared with marketed acalabrutinib capsule (Treatment B) in the fasted state.

Primary Outcome

To compare the AUCinf of acalabrutinib capsule with the tablet.

Interventions

  • DRUG Treatment A: Acalabrutinib tablet
  • DRUG Treatment B: Acalabrutinib capsule

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2021-02-25
Est. Completion 2021-05-10
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT04768985 record still lists

NCT04768985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% higher).

The record links to 0 conditions, and to 2 interventions - of which Treatment A: Acalabrutinib tablet is the first listed.

NCT04768985 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04768985 about?

NCT04768985 is a clinical study titled "Study to Assess the Bioequivalence of Acalabrutinib Tablet and Acalabrutinib Capsule". This study is a multicenter, Phase I, open-label, randomized, 2-sequence, 2-treatment, 2-period, crossover, bioequivalence study with single doses of acalabrutinib administered orally in healthy participants. The study is designed to demonstrate the bioequivalence of acalabrutinib tablet (Treatment ...

What is the current status of trial NCT04768985?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2021-02-25. Estimated completion is 2021-05-10.

What interventions are being tested in trial NCT04768985?

The interventions under investigation include: Treatment A: Acalabrutinib tablet (DRUG), Treatment B: Acalabrutinib capsule (DRUG).

Who is sponsoring clinical trial NCT04768985?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04768985's enrollment target sits among peer trials

66 786th of 2000 higher than 1,203 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 NCT04768985, the US trial registry maintained by the National Library of Medicine. NCT04768985 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.