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NCT04488016 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects

A Phase 1 study of Bioavailability and B-cell Lymphoid Cancer, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target
1
Study location

NCT04488016 is a Phase 1 study of Bioavailability and B-cell Lymphoid Cancer that has completed, run by AstraZeneca. The registered enrollment target is 54 participants, above the 31-participant average among 8 other Bioavailability trials with a reported enrollment target (74% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT04488016, a Phase 1 study of Bioavailability and B-cell Lymphoid Cancer, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety and Pharmacokinetics (PK) data from Part 1, the study is planned to be continued with Part 2.

Interventions

  • DRUG Treatment A- Part 1
  • DRUG Treatment B- Part 1
  • DRUG Treatment C - Part 1
  • DRUG Treatment D- Part 1
  • DRUG Treatment A-Part 2

Study Locations (1)

Maryland

  • Research Site - Baltimore

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2020-06-24
Est. Completion 2021-01-20
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT04488016

The ClinicalTrials.gov registry entry for NCT04488016 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 31-participant average among 8 other Bioavailability trials with a reported enrollment target (74% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Bioavailability appearing as the primary indexed condition, and to 5 interventions - of which Treatment A- Part 1 is the first listed.

NCT04488016 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04488016 about?

NCT04488016 is a clinical study titled "A Study to Evaluate Relative Bioavailability, Proton Pump Inhibitor (PPI) (Rabeprazole) Effect, Food Effect and Particle Size Effect of New Acalabrutinib Tablet in Healthy Subjects". This study will be a 2-part, open-label, single-center relative bioavailability, PPI effect, food-effect and particle size effect randomized crossover study of acalabrutinib tablets in healthy subjects (males or females). The study will be divided in 2 study parts; following a review of the safety a...

What is the current status of trial NCT04488016?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2020-06-24. Estimated completion is 2021-01-20.

What conditions does trial NCT04488016 study?

This clinical trial studies the following conditions: Bioavailability, B-cell Lymphoid Cancer.

What interventions are being tested in trial NCT04488016?

The interventions under investigation include: Treatment A- Part 1 (DRUG), Treatment B- Part 1 (DRUG), Treatment C - Part 1 (DRUG), Treatment D- Part 1 (DRUG), Treatment A-Part 2 (DRUG).

Who is sponsoring clinical trial NCT04488016?

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

Where is trial NCT04488016 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.