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NCT01518985 · ClinicalTrials.gov registry record · Phase 1
The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking
A Phase 1 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01518985: Completed Phase 1 study, sponsored by Stealth BioTherapeutics.
NCT01518985 is a Phase 1 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01518985, a Phase 1 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.
Primary Outcome
Endothelial function will be determined using EndoPAT 2000 (Itamar Medical Ltd) prior to and after smoking of one unfiltered cigarette and prior to and after initiation of study drug. Group comparison of endothelial function (EndoPAT Index) between placebo and active study drug within a subject will be performed. EndoPAT quantifies the endothelium-mediated changes in vascular tone. A post-occlusion to pre-occlusion ratio is calculated providing the EndoPAT index.
Interventions
- DRUG Bendavia
- DRUG Sterile saline (0.9%)
- OTHER Cigarette smoking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01518985 record still lists
NCT01518985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Bendavia is the first listed.
NCT01518985 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01518985 about?
NCT01518985 is a clinical study titled "The Impact of Intravenous Bendavia™ on Endothelial Reactivity Dysfunction in Cigarette Smoking". This will be a phase 1 randomized, double-blind, 2-period, 2-sequence crossover trial enrolling 6 healthy volunteers to assess the impact of IV-administered Bendavia on the endothelial dysfunction induced by a single cigarette.
What is the current status of trial NCT01518985?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2012-01. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01518985?
The interventions under investigation include: Bendavia (DRUG), Sterile saline (0.9%) (DRUG), Cigarette smoking (OTHER).
Who is sponsoring clinical trial NCT01518985?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01518985's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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