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NCT02709265 · ClinicalTrials.gov registry record · Phase 1

Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers

A Phase 1 study of Healthy, sponsored by Cardeas Pharma.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT02709265 is a Phase 1 study of Healthy that has completed, run by Cardeas Pharma. The registered enrollment target is 30 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02709265, a Phase 1 study of Healthy, has completed, sponsored by Cardeas Pharma.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12 mg, 60/24 mg, 90/36 mg amikacin/fosfomycin) will be evaluated. Following this evaluation, a single dose and nebulizer will be chosen to further evaluate systemic, bronchoalveolar, and urine pharmacokinetics in spontaneously breathing healthy volunteers.

Conditions Studied

Healthy

Interventions

  • DRUG amikacin/fosfomycin

Study Locations (1)

Minnesota

  • DaVita Clinical Research - Minneapolis

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2016-04
Est. Completion 2016-07
Phase Phase 1

Sponsor

Cardeas Pharma

2 total trials

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What the Registry Record Tells You About NCT02709265

The ClinicalTrials.gov registry entry for NCT02709265 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower). The listed sponsor is Cardeas Pharma, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which amikacin/fosfomycin is the first listed.

NCT02709265 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT02709265 about?

NCT02709265 is a clinical study titled "Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers". This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing healthy volunteers following a single dose of amikacin/fosfomycin, using the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer. Three doses (30/12 mg, 60/24 mg, 90/36 mg amikacin/fosfomy...

What is the current status of trial NCT02709265?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-04. Estimated completion is 2016-07.

What conditions does trial NCT02709265 study?

This clinical trial studies the following conditions: Healthy.

What interventions are being tested in trial NCT02709265?

The interventions under investigation include: amikacin/fosfomycin (DRUG).

Who is sponsoring clinical trial NCT02709265?

This trial is sponsored by Cardeas Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02709265 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.