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NCT03914755 · ClinicalTrials.gov registry record · Phase 1
A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects
A Phase 1 study, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT03914755: Completed Phase 1 study, sponsored by Seagen.
NCT03914755 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03914755, a Phase 1 study, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants. Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tucatinib over 14 days with and without food. Subjects will be in the study for up to 45 days, including the screening period. Due to practical considerations, each cohort will be dosed sequentially (this is not a dose escalation study).
Interventions
- DRUG Tucatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2019-08-04 |
| Phase | Phase 1 |
What the finished NCT03914755 record still lists
NCT03914755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 1 intervention - of which Tucatinib is the first listed.
NCT03914755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03914755 about?
NCT03914755 is a clinical study titled "A Safety, Tolerability, and Pharmacokinetic Study of Tucatinib in Healthy Japanese and Caucasian Subjects". This study is being done to compare the pharmacokinetics (PK) and safety/tolerability of tucatinib in healthy Japanese and Caucasian participants. Three cohorts of healthy Japanese and Caucasian men and women will be admitted to the Clinical Research Unit (CRU) and receive multiple oral doses of tu...
What is the current status of trial NCT03914755?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2019-05-08. Estimated completion is 2019-08-04.
What interventions are being tested in trial NCT03914755?
The interventions under investigation include: Tucatinib (DRUG).
Who is sponsoring clinical trial NCT03914755?
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 NCT03914755's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 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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