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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: Completed Phase 1 study, sponsored by Seagen.
NCT03723395 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 116 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PK parameters for tucatinib (Parts A, B, and C); repaglinide and its M4 metabolite (Part D), tolbutamide and its 4-hydroxytolbutamide metabolite (Part D), midazolam and its 1-hydroxymidazolam metabolite (Part D), and digoxin (Part E)
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 |
What the finished NCT03723395 record still lists
NCT03723395 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% higher).
The record links to 0 conditions, and to 5 interventions - of which itraconazole is the first listed.
NCT03723395 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03723395's enrollment target sits among peer trials
116 501st of 2000 higher than 1,497 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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