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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04121910
The ClinicalTrials.gov registry entry for NCT04121910 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Itraconazole is the first listed.
NCT04121910 reports 0 study locations.
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.
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