Ignite Creation Date:
2024-05-06 @ 8:17 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02709265
Status:
COMPLETED
Last Update Posted:
2016-07-11
First Post:
2016-03-08
Brief Title:
Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers
Sponsor:
Cardeas Pharma
Organization:
Cardeas Pharma
Study Overview
Official Title:
An Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin Delivered Via the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate systemic and urine pharmacokinetics in spontaneously breathing healthy volunteers following a single dose of amikacinfosfomycin using the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer Three doses 3012 mg 6024 mg 9036 mg amikacinfosfomycin 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
Detailed Description:
This is a Phase 1 open-label study of three doses of amikacinfosfomycin Approximately 30 healthy volunteers will be dosed in five cohorts of six subjects each The first sentinel subject in each of the first three cohorts will be dosed alone If no significant safety or tolerability events occur the remaining five subjects in each of the first three cohorts will be dosed The first cohort n6 will be administered the 3012 mg dose of amikacinfosfomycin The second cohort n6 will be administered the 6024 mg dose of amikacinfosfomycin The third cohort n6 will be administered the 9036 mg dose of amikacinfosfomycin All doses in cohorts 1 2 and 3 will be delivered with the PARI Investigational eFlow Nebulizer System The fourth cohort n6 will be administered the 9036 mg dose of amikacinfosfomycin using the PARI LC Sprint Nebulizer The fifth cohort n6 will test the lowest dose level at which all subjects achieved 03 µgmL amikacin peak serum concentration The nebulizer used to deliver doses in cohort 5 will be determined after amikacin concentrations from cohorts 1 through 4 are reviewed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None