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NCT03777761 · ClinicalTrials.gov registry record · Phase 1
Effects of Tucatinib on Cardiac Repolarization in Healthy Participants
A Phase 1 study of Healthy, sponsored by Seagen.
- Completed
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03777761: Completed Phase 1 study of Healthy, sponsored by Seagen.
NCT03777761 is a Phase 1 study of Healthy that has completed, run by Seagen. The registered enrollment target is 55 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03777761, a Phase 1 study of Healthy, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug, the second part will be to take a placebo (pill with no medicine), and the third part will be to take moxifloxacin. The volunteers will only know what part of the study they are in when they take moxifloxacin. For the study drug and placebo parts, volunteers will take 2 pills by mouth for 5 days. For the moxifloxacin part, volunteers will take 1 pill by mouth for 1 day.
Primary Outcome
QTcF is the QT interval corrected for heart rate using Fridericia's method.
Conditions Studied
Interventions
- DRUG placebo
- DRUG tucatinib
- DRUG moxifloxacin
Study Locations (1)
Texas
- Covance Clinical Research Unit - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2019-03-11 |
| Phase | Phase 1 |
What the finished NCT03777761 record still lists
NCT03777761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT03777761 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03777761 about?
NCT03777761 is a clinical study titled "Effects of Tucatinib on Cardiac Repolarization in Healthy Participants". This study is looking at how the study drug, tucatinib, affects the heart. Tucatinib is being studied as a possible treatment for breast cancer. This study will recruit healthy volunteers. There are 3 parts in the study. Each volunteer will be in all 3 parts. One part will be to take the study drug,...
What is the current status of trial NCT03777761?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2018-12-06. Estimated completion is 2019-03-11.
What conditions does trial NCT03777761 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT03777761?
The interventions under investigation include: placebo (DRUG), tucatinib (DRUG), moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT03777761?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03777761 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03777761's enrollment target sits among peer trials
55 427th of 1090 higher than 659 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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