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NCT04991571 · ClinicalTrials.gov registry record · Phase 1
Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT04991571: Completed Phase 1 study, sponsored by AstraZeneca.
NCT04991571 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04991571, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapagliflozin after dosing with two different fixed-dose combination (FDC) formulations and dosing with separate formulations of zibotentan and dapagliflozin.
Primary Outcome
Plasma sample will be collected to understand the PK profiling of zibotentan metabolites and to meet the regulatory requirements.
Interventions
- DRUG Zibotentan (Treatment A)
- DRUG Dapagliflozin (Treatment A)
- DRUG Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)
- DRUG Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-07-29 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
What the finished NCT04991571 record still lists
NCT04991571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Zibotentan (Treatment A) is the first listed.
NCT04991571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04991571 about?
NCT04991571 is a clinical study titled "Study to Collect Samples for MIST Analysis of Zibotentan and Bioavailability of Zibotentan and Dapagliflozin in Heatlhy Participants". The study will have 2 independent parts: Part 1 of the study is intended to collect samples for Metabolites in Safety Testing (MIST) analysis after administration of multiple doses of zibotentan. Part 2 of the study is designed to evaluate the relative bioavailability of zibotentan and dapaglifloz...
What is the current status of trial NCT04991571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2021-07-29. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT04991571?
The interventions under investigation include: Zibotentan (Treatment A) (DRUG), Dapagliflozin (Treatment A) (DRUG), Zibotentan/Dapagliflozin - Formulation 1 (Treatment B) (DRUG), Zibotentan/Dapagliflozin - Formulation 2 (Treatment C) (DRUG).
Who is sponsoring clinical trial NCT04991571?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04991571's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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