NCT02709265

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

March 8, 2016

Last Update Submit

July 8, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Peak plasma concentration (Cmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI Investigational eFlow Nebulizer System

    10 minutes to 24 hours post-dose

  • Peak plasma concentration (Cmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI LC Sprint Nebulizer

    10 minutes to 24 hours post-dose

Secondary Outcomes (5)

  • Time to peak plasma concentration (Tmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI Investigational eFlow Nebulizer System

    10 minutes to 24 hours post-dose

  • Time to peak plasma concentration (Tmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI LC Sprint Nebulizer

    10 minutes to 24 hours post-dose

  • Plasma area under the concentration-time curve (AUC) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI Investigational eFlow Nebulizer System

    10 minutes to 24 hours post-dose

  • Plasma area under the concentration-time curve (AUC) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI LC Sprint Nebulizer

    10 minutes to 24 hours post-dose

  • Peak bronchoalveolar lavage concentration (Cmax) of amikacin/fosfomycin following delivery of nebulized 30/12 mg, 60/24 mg, or 90/36 mg amikacin/fosfomycin via the PARI Investigational eFlow Nebulizer System or the PARI LC Sprint Nebulizer

    30 minutes post-dose

Other Outcomes (5)

  • Peak urine concentration (Cmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI Investigational eFlow Nebulizer System

    0 - 6 hours; 6 - 12 hours; and 12 - 24 hours post-dose

  • Peak urine concentration (Cmax) of nebulized amikacin/fosfomycin following delivery of 30/12 mg, 60/24 mg, and 90/36 mg amikacin/fosfomycin via the PARI LC Sprint Nebulizer

    0 - 6 hours; 6 - 12 hours; and 12 - 24 hours post-dose

  • Number of subjects with treatment-related adverse events

    0 - 24 hours post-dose

  • +2 more other outcomes

Study Arms (5)

Cohort 1

EXPERIMENTAL

amikacin/fosfomycin (30/12 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)

Drug: amikacin/fosfomycin

Cohort 2

EXPERIMENTAL

amikacin/fosfomycin (60/24 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)

Drug: amikacin/fosfomycin

Cohort 3

EXPERIMENTAL

amikacin/fosfomycin (90/36 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)

Drug: amikacin/fosfomycin

Cohort 4

EXPERIMENTAL

amikacin/fosfomycin (90/36 mg) delivered via the PARI LC Sprint Nebulizer (single dose)

Drug: amikacin/fosfomycin

Cohort 5

EXPERIMENTAL

amikacin/fosfomycin (Dose and Nebulizer to be chosen based on results from Cohorts 1 - 4)

Drug: amikacin/fosfomycin

Interventions

amikacin/fosfomycinDRUG

single aerosolized dose

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females aged ≥18 years and ≤ 80 years of age (Cohorts 1, 2, 3, and 4). Males or females aged ≥ 18 years and ≤ 65 years of age (Cohort 5).
  • Females of childbearing potential must be using contraception. Acceptable methods of contraception include male or female condom with spermicide gel or foam, hormonal contraceptive combined with a condom, Intrauterine Device (IUD), tubal ligation, diaphragm with spermicide, or total abstinence with a back-up if the subject becomes active.
  • Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.

You may not qualify if:

  • History of previous allergy or sensitivity to amikacin or fosfomycin.
  • Use of oral fosfomycin in the 28 days prior to admission to Phase 1 facility.
  • History of reactive airways disease (such as asthma or chronic obstructive pulmonary disease \[COPD\]), cystic fibrosis, or bronchiectasis.
  • Human Immunodeficiency Virus (HIV) positive.
  • Active Hepatitis B or C.
  • Cigarette/e-Cigarette smoking or use of other nicotine or tobacco containing products within seven days prior to study drug administration.
  • Positive for drugs of abuse or alcohol use at screening or admission to Phase 1 facility. A Breathalyzer test will be used to screen for the presence of alcohol. A urine standard panel will be used to test for the following substances (with serum testing for confirmation, as needed):
  • Opiates
  • Oxycodone
  • Methadone
  • Cocaine
  • Tetrahydrocannabinol (THC)
  • Benzodiazepines
  • Amphetamines / Methamphetamines
  • Barbiturates
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Interventions

AmikacinFosfomycin

Intervention Hierarchy (Ancestors)

KanamycinAminoglycosidesGlycosidesCarbohydratesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 16, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)