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NCT01706679 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Effect of ATX-101 on QT/QTc Intervals
A Phase 1 study, sponsored by Kythera Biopharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 218
- Enrollment target
NCT01706679: Completed Phase 1 study, sponsored by Kythera Biopharmaceuticals.
NCT01706679 is a Phase 1 study that has completed, run by Kythera Biopharmaceuticals. The registered enrollment target is 218 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (263% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01706679, a Phase 1 study, has completed, sponsored by Kythera Biopharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 218 participants
- Enrollment target
Study Summary
To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
Primary Outcome
The primary endpoint will be the mean change between time-matched measurements of QTcF for ATX-101 and placebo after baseline adjustment calculating the upper bound of the one-sided 95% confidence interval. A negative TQT study can be claimed if each upper bound of the one-sided 95% CI is below 10 msec.
Interventions
- DRUG ATX-101 (10 mg/ml)
- DRUG ATX-101 (20 mg/ml)
- DRUG Moxifloxacin (400 mg)
- DRUG Placebo vehicle (PBS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
What the finished NCT01706679 record still lists
NCT01706679 is an interventional study that assigns participants to a tested intervention. The registered 218 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 (263% higher).
The record links to 0 conditions, and to 4 interventions - of which ATX-101 (10 mg/ml) is the first listed.
NCT01706679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01706679 about?
NCT01706679 is a clinical study titled "Evaluation of the Effect of ATX-101 on QT/QTc Intervals". To evaluate the effect of maximum therapeutic and supratherapeutic doses of ATX-101 treatment on Fridericia's corrected QT interval (QTcF).
What is the current status of trial NCT01706679?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2012-10. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01706679?
The interventions under investigation include: ATX-101 (10 mg/ml) (DRUG), ATX-101 (20 mg/ml) (DRUG), Moxifloxacin (400 mg) (DRUG), Placebo vehicle (PBS) (DRUG).
Who is sponsoring clinical trial NCT01706679?
This trial is sponsored by Kythera Biopharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01706679's enrollment target sits among peer trials
218 239th of 2000 higher than 1,761 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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