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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 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 36 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03914755
The ClinicalTrials.gov registry entry for NCT03914755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 1 intervention - of which Tucatinib is the first listed.
NCT03914755 reports 0 study locations.
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.
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