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NCT04187456 · ClinicalTrials.gov registry record · Phase 1
A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT04187456: Completed Phase 1 study, sponsored by AstraZeneca.
NCT04187456 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04187456, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.
Primary Outcome
To assess the effect of savolitinib on the PK of midazolam.
Interventions
- DRUG Midazolam
- DRUG Savolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 1 |
What the finished NCT04187456 record still lists
NCT04187456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT04187456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04187456 about?
NCT04187456 is a clinical study titled "A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body". This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.
What is the current status of trial NCT04187456?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2019-12-27. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT04187456?
The interventions under investigation include: Midazolam (DRUG), Savolitinib (DRUG).
Who is sponsoring clinical trial NCT04187456?
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 NCT04187456's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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