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NCT01353729 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers
A Phase 1 study of Influenza, Human, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01353729: Completed Phase 1 study of Influenza, Human, sponsored by GlaxoSmithKline.
NCT01353729 is a Phase 1 study of Influenza, Human that has completed, run by GlaxoSmithKline. The registered enrollment target is 40 participants, below the 16,221-participant average among 18 other Influenza, Human trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01353729, a Phase 1 study of Influenza, Human, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in the unit until Day 2. Each subject will receive a single dose of each of the four treatments on Day 1 of each treatment period in a randomized fashion. Subjects will be discharged from the clinical research unit after the completion of all assessments on Day 2 of each period and return approximately 5-7 days later for the next dose period. Serial pharmacokinetic samples will be collected for up to 24 hours following each treatment.
Conditions Studied
Interventions
- DRUG 600 mg zanamivir + moxifloxacin placebo
- DRUG 1200 mg zanamivir + moxifloxacin placebo
- DRUG zanamivir placebo + moxifloxacin placebo
- DRUG zanamivir placebo + 400 mg moxifloxacin
Study Locations (1)
Texas
- GSK Investigational Site - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-05-19 |
| Est. Completion | 2011-08-02 |
| Phase | Phase 1 |
What the finished NCT01353729 record still lists
NCT01353729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 16,221-participant average among 18 other Influenza, Human trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 4 interventions - of which 600 mg zanamivir + moxifloxacin placebo is the first listed.
NCT01353729 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01353729 about?
NCT01353729 is a clinical study titled "A Study to Evaluate the Effect of Intravenous Zanamivir on Cardiac Conduction in Healthy Volunteers". Approximately 40 healthy subjects will be enrolled. Each subject will participate in the study for approximately 9 weeks. There will be four treatment sequences with a 5-7 day washout between treatments. Subjects will be admitted to the clinical unit on Day-1 of each dosing period and will remain in...
What is the current status of trial NCT01353729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2011-05-19. Estimated completion is 2011-08-02.
What conditions does trial NCT01353729 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT01353729?
The interventions under investigation include: 600 mg zanamivir + moxifloxacin placebo (DRUG), 1200 mg zanamivir + moxifloxacin placebo (DRUG), zanamivir placebo + moxifloxacin placebo (DRUG), zanamivir placebo + 400 mg moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT01353729?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01353729 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
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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 NCT01353729's enrollment target sits among peer trials
40 16th of 18 higher than 3 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human 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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