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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 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 60 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02770404
The ClinicalTrials.gov registry entry for NCT02770404 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02770404 reports 0 study locations.
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.
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