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NCT02453529 · ClinicalTrials.gov registry record · Phase 1
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects
A Phase 1 study, sponsored by Wockhardt.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT02453529 is a Phase 1 study that has completed, run by Wockhardt. The registered enrollment target is 36 participants.
The verdict
NCT02453529, a Phase 1 study, has completed, sponsored by Wockhardt.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects. Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873. The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing. Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for determining plasma WCK 4873 concentrations at 48 hours after the third dose. Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests (including liver function tests), ECG, physical examination and vital sign monitoring. Subjects will discontinue study drug administration in the event of AST/ALT elevation of greater than 3 times the upper limit of normal.
Interventions
- DRUG WCK 4873
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02453529
The ClinicalTrials.gov registry entry for NCT02453529 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 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 1 intervention - of which WCK 4873 is the first listed.
NCT02453529 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02453529 about?
NCT02453529 is a clinical study titled "Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects". This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects. Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within ...
What is the current status of trial NCT02453529?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2015-04. Estimated completion is 2015-07.
What interventions are being tested in trial NCT02453529?
The interventions under investigation include: WCK 4873 (DRUG).
Who is sponsoring clinical trial NCT02453529?
This trial is sponsored by Wockhardt, which has 27 total clinical trials registered on ClinicalTrials.gov.
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