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drugset / Trial / NCT02709265

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

NCT02709265 ↗

Phase 1 Completed 30 enrolled Cardeas Pharma
Non-randomizedSingle-groupOpen-label

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.

Timeline

Start
2016-04
Primary completion
2016-07
Completion
2016-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Amikacin Small molecule 30 mg Other
Subject Amikacin Small molecule 60 mg Other
Subject Amikacin Small molecule 90 mg Other
Subject Fosfomycin Small molecule 12 mg Other
Subject Fosfomycin Small molecule 24 mg Other
Subject Fosfomycin Small molecule 36 mg Other

Indications

No indication recorded.