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NCT02770404 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
A Phase 1 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT02770404: Completed Phase 1 study, sponsored by Wockhardt.
NCT02770404 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02770404, a Phase 1 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.
Interventions
- DRUG Placebo
- DRUG Nafithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2016-12-25 |
| Phase | Phase 1 |
What the finished NCT02770404 record still lists
NCT02770404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02770404 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02770404 about?
NCT02770404 is a clinical study titled "A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects". This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 ...
What is the current status of trial NCT02770404?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2016-04-25. Estimated completion is 2016-12-25.
What interventions are being tested in trial NCT02770404?
The interventions under investigation include: Placebo (DRUG), Nafithromycin (DRUG).
Who is sponsoring clinical trial NCT02770404?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02770404's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 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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