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NCT03910673 · ClinicalTrials.gov registry record · Phase 1
Intravenous Fosfomycin Pharmacokinetics Study
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
NCT03910673 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 39 participants.
The verdict
NCT03910673, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronchoscopy with bronchoalveolar lavage (BAL) at one of five sampling times. A total of 6 subjects will be assigned to each BAL-sampling time. Up to ten additional enrolled subjects will act as alternates to obtain 30 evaluable subjects. An evaluable subject is defined as a subject who receives all doses of ZTI-01, undergoes BAL at the randomized sampling timepoint with BAL return volume adequate for testing, and undergoes at least the one blood sampling timepoint that is concurrent with the assigned BAL sampling timepoint, with blood sampling volume that is adequate for testing. The objectives of the study are to assess safety and pharmacokinetics (PK) for a multiple dose regimen of IV-infused ZTI-01.
Interventions
- DRUG Fosfomycin disodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-06-27 |
| Est. Completion | 2020-12-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910673
The ClinicalTrials.gov registry entry for NCT03910673 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Fosfomycin disodium is the first listed.
NCT03910673 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03910673 about?
NCT03910673 is a clinical study titled "Intravenous Fosfomycin Pharmacokinetics Study". This is a Phase 1, open-label, multiple-dose trial conducted at a single center. The treatment period will consist of three 6 g doses (18 g) of ZTI-01 as a 1-hour intravenous (IV) infusion (+10 minute window). A total of 30 enrolled subjects will be randomized to undergo a single standardized bronch...
What is the current status of trial NCT03910673?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2019-06-27. Estimated completion is 2020-12-17.
What interventions are being tested in trial NCT03910673?
The interventions under investigation include: Fosfomycin disodium (DRUG).
Who is sponsoring clinical trial NCT03910673?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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