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HealthyPhase 1NCT02709265

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

A Phase 1 study testing amikacin/fosfomycin in people with Healthy, run by Cardeas Pharma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
amikacin/fosfomycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2016to Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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
  • Methylenedioxy-methamphetamine (MDMA)
  • Phenylcyclohexyl piperidine (PCP)
  • Tricyclic Antidepressants
  • Participation in a clinical study with administration of an investigational drug product within the previous 30 days, or five half-lives of the previously administered investigational product.
  • Donation of blood or significant blood loss within the 8 weeks prior to admission to Phase 1 facility.
  • Donation of plasma within the week prior to admission to Phase 1 facility.
  • Any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk.
  • Pregnant or nursing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • DaVita Clinical Research

    Minneapolis, Minnesota, 55404

Other trials in United States

About this study

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

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.

Read the detailed description

This is a Phase 1 open-label study of three doses of amikacin/fosfomycin. 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 (n=6) will be administered the 30/12 mg dose of amikacin/fosfomycin. The second cohort (n=6) will be administered the 60/24 mg dose of amikacin/fosfomycin. The third cohort (n=6) will be administered the 90/36 mg dose of amikacin/fosfomycin. All doses in cohorts 1, 2, and 3 will be delivered with the PARI Investigational eFlow Nebulizer System. The fourth cohort (n=6) will be administered the 90/36 mg dose of amikacin/fosfomycin using the PARI LC Sprint Nebulizer. The fifth cohort (n=6) will test the lowest dose level at which all subjects achieved > 0.3 µg/mL 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.

Conditions
Healthy
Being tested
amikacin/fosfomycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • amikacin/fosfomycinDrug

    single aerosolized dose

Study groups in NCT02709265
Study groupRoleWhat they receive
Cohort 1Experimentalamikacin/fosfomycin (30/12 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)
Receives: Drug: amikacin/fosfomycin
Cohort 2Experimentalamikacin/fosfomycin (60/24 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)
Receives: Drug: amikacin/fosfomycin
Cohort 3Experimentalamikacin/fosfomycin (90/36 mg) delivered via the PARI Investigational eFlow Nebulizer (single dose)
Receives: Drug: amikacin/fosfomycin
Cohort 4Experimentalamikacin/fosfomycin (90/36 mg) delivered via the PARI LC Sprint Nebulizer (single dose)
Receives: Drug: amikacin/fosfomycin
Cohort 5Experimentalamikacin/fosfomycin (Dose and Nebulizer to be chosen based on results from Cohorts 1 - 4)
Receives: Drug: amikacin/fosfomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 10 minutes to 24 hours post-dose

  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 LC Sprint Nebulizer

    Measured: 10 minutes to 24 hours post-dose

Secondary outcomes (5)

  1. 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

    Measured: 10 minutes to 24 hours post-dose

  2. 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

    Measured: 10 minutes to 24 hours post-dose

  3. 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

    Measured: 10 minutes to 24 hours post-dose

  4. 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

    Measured: 10 minutes to 24 hours post-dose

  5. 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

    The dose and nebulizer used for Cohort 5 will be chosen based on plasma Cmax results from Cohorts 1 - 4.

    Measured: 30 minutes post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709265
Sponsor's protocol ID
CAP-01-104
Status last verified
Jul 2016
First submitted
8 Mar 2016
Last updated
11 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing amikacin/fosfomycin in people with Healthy, run by Cardeas Pharma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 10 minutes to 24 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02709265.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.

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