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NCT03723395 · ClinicalTrials.gov registry record · Phase 1
A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 116
- Enrollment target
NCT03723395 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 116 participants.
The verdict
NCT03723395, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 116 participants
- Enrollment target
Study Summary
This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how the body breaks down tucatinib when there are lower levels of certain liver enzymes. Part B is looking at how the body breaks down tucatinib when there are high levels of certain liver and stomach enzymes. Parts D and E are looking at how tucatinib could change the levels of some liver and stomach enzymes in the body. This will help us know more about how tucatinib should be given to patients.
Interventions
- DRUG itraconazole
- DRUG tucatinib
- DRUG rifampin
- DRUG repaglinide
- DRUG gemfibrozil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2018-12-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03723395
The ClinicalTrials.gov registry entry for NCT03723395 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 84 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which itraconazole is the first listed.
NCT03723395 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03723395 about?
NCT03723395 is a clinical study titled "A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib". This study is being done to look at how tucatinib could affect the way other drugs work. This study will look at healthy volunteers and how tucatinib affects their liver enzymes. Liver enzymes can change how drugs work in the body. There are 5 parts to this study. Parts A and C are looking at how th...
What is the current status of trial NCT03723395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2018-09-17. Estimated completion is 2018-12-28.
What interventions are being tested in trial NCT03723395?
The interventions under investigation include: itraconazole (DRUG), tucatinib (DRUG), rifampin (DRUG), repaglinide (DRUG), gemfibrozil (DRUG).
Who is sponsoring clinical trial NCT03723395?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
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