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NCT02942810 · ClinicalTrials.gov registry record · Phase 1
To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment
A Phase 1 study of Renal Impairment, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT02942810 is a Phase 1 study of Renal Impairment that has completed, run by Wockhardt. The registered enrollment target is 48 participants, above the 33-participant average among 32 other Renal Impairment trials with a reported enrollment target (45% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02942810, a Phase 1 study of Renal Impairment, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function). The severity of renal impairment will be assessed based on estimated creatinine clearance (CLCR) by the Cockcroft-Gault equation
Conditions Studied
Interventions
- DRUG WCK 5222
Study Locations (1)
Florida
- University of Miami,Division of Clinical Pharmacology - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-10-25 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02942810
The ClinicalTrials.gov registry entry for NCT02942810 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 33-participant average among 32 other Renal Impairment trials with a reported enrollment target (45% higher). The listed sponsor is Wockhardt, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Impairment appearing as the primary indexed condition, and to 1 intervention - of which WCK 5222 is the first listed.
NCT02942810 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT02942810 about?
NCT02942810 is a clinical study titled "To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment". This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage ...
What is the current status of trial NCT02942810?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2016-10-25. Estimated completion is 2017-04.
What conditions does trial NCT02942810 study?
This clinical trial studies the following conditions: Renal Impairment.
What interventions are being tested in trial NCT02942810?
The interventions under investigation include: WCK 5222 (DRUG).
Who is sponsoring clinical trial NCT02942810?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02942810 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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