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NCT04121910 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04121910: Completed Phase 1 study, sponsored by AstraZeneca.
NCT04121910 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04121910, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will be conducted to quantify the magnitude of the effect of itraconazole co-administration on the PK of savolitinib. The exposure to savolitinib is predicted to increase when co-administered with the potent cytochrome P (CYP) 3A4 inhibitor itraconazole since CYP3A4 (via CYP450) is involved in the metabolism and elimination of savolitinib.
Primary Outcome
To assess the effect of itraconazole on the PK of savolitinib
Interventions
- DRUG Itraconazole
- DRUG Savolitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2020-01-12 |
| Phase | Phase 1 |
What the finished NCT04121910 record still lists
NCT04121910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Itraconazole is the first listed.
NCT04121910 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04121910 about?
NCT04121910 is a clinical study titled "A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole". This study will be conducted to quantify the magnitude of the effect of itraconazole co-administration on the PK of savolitinib. The exposure to savolitinib is predicted to increase when co-administered with the potent cytochrome P (CYP) 3A4 inhibitor itraconazole since CYP3A4 (via CYP450) is involv...
What is the current status of trial NCT04121910?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-11-07. Estimated completion is 2020-01-12.
What interventions are being tested in trial NCT04121910?
The interventions under investigation include: Itraconazole (DRUG), Savolitinib (DRUG).
Who is sponsoring clinical trial NCT04121910?
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 NCT04121910's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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