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NCT04958226 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT04958226: Completed Phase 1 study, sponsored by AstraZeneca.
NCT04958226 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04958226, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will be assessed when administered alone and in combination with repeated doses of capivasertib.
Primary Outcome
Area under the plasma concentration-time curve from zero to infinity
Interventions
- DRUG Midazolam
- DRUG Capivasertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 1 |
What the finished NCT04958226 record still lists
NCT04958226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT04958226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04958226 about?
NCT04958226 is a clinical study titled "A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours". This is an open-label, fixed-sequence study to evaluate the effect of capivasertib on the pharmacokinetics (PK) of midazolam, a sensitive CYP3A substrate. The PK of midazolam will be assessed when administered alone and in combination with repeated doses of capivasertib.
What is the current status of trial NCT04958226?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2021-10-15. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT04958226?
The interventions under investigation include: Midazolam (DRUG), Capivasertib (DRUG).
Who is sponsoring clinical trial NCT04958226?
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 NCT04958226's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 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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