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NCT05241535 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects
A Phase 1 study of Healthy Subjects, sponsored by Tanabe Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT05241535: Completed Phase 1 study of Healthy Subjects, sponsored by Tanabe Pharma America.
NCT05241535 is a Phase 1 study of Healthy Subjects that has completed, run by Tanabe Pharma America. The registered enrollment target is 29 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05241535, a Phase 1 study of Healthy Subjects, has completed, sponsored by Tanabe Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the QT/QTc interval in healthy subjects.
Primary Outcome
The upper bound of the one-sided 95% confidence interval (CI) for the ΔΔQTcF at geometric mean Cmax (maximum plasma concentration) level is \<10 milliseconds.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MT-7117
- DRUG moxifloxacin
Study Locations (2)
Florida
- Daytona Beach Clinical Research Unit - Daytona Beach
Texas
- Dallas Clinical Research Unit - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2022-02-27 |
| Phase | Phase 1 |
What the finished NCT05241535 record still lists
NCT05241535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05241535 reports a single indexed study location in Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT05241535 about?
NCT05241535 is a clinical study titled "Study to Evaluate the Effect of a Single Oral Dose of MT-7117 on the QT/QTc Interval in Healthy Subjects". The purpose of this study is to evaluate the effect of a single oral dose of MT-7117 on the QT/QTc interval in healthy subjects.
What is the current status of trial NCT05241535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2022-01-12. Estimated completion is 2022-02-27.
What conditions does trial NCT05241535 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT05241535?
The interventions under investigation include: Placebo (DRUG), MT-7117 (DRUG), moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT05241535?
This trial is sponsored by Tanabe Pharma America, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05241535 being conducted?
This trial has 2 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05241535's enrollment target sits among peer trials
29 41st of 69 higher than 29 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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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