Open-Label Phase 1 Study of Aerosolized Amikacin and Fosfomycin in Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02709265
- Run by
- Cardeas Pharma
- People needed
- 30
- Starts
- 2016-04-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-07-11
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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
- 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.
Where it is running
- DaVita Clinical Research — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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