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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: Completed Phase 1 study of Bioavailability and B-cell Lymphoid Cancer, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Part 1: To assess the relative bioavailability of the acalabrutinib tablet compared with acalabrutinib capsules in fasted state. Part 2: To assess the impact of drug substance particle size on the bioavailability of acalabrutinib tablets.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2020-06-24 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 1 |
What the finished NCT04488016 record still lists
NCT04488016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, above the 31-participant average among 8 other Bioavailability trials with a reported enrollment target (74% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04488016's enrollment target sits among peer trials
54 3rd of 8 higher than 6 of 8 other Bioavailability trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bioavailability 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.
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