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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: Completed Phase 1 study of Healthy, sponsored by Cardeas Pharma.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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
Cardeas Pharma

2 total trials

What the finished NCT02709265 record still lists

NCT02709265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (95% lower).

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 a single indexed study location in 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.

Similar trials for Healthy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02709265's enrollment target sits among peer trials

30 678th of 1090 higher than 363 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02709265, the US trial registry maintained by the National Library of Medicine. NCT02709265 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.