Pharmacokinetics of Enrofloxacin in Plasma and Urine

NCT03575312 | Completed

• 1 other identifier: 18-02 EnroHuman
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Antibiotics like enrofloxacin are widely used in animal farming to treat and prevent bacterial infections. A previous study in poultry farms has shown that yardmen show significant concentrations of administered antibiotics in their urine. It is currently unclear how poultry yardmen are exposed to the administered antibiotics. The objective of this exemplarily study is to obtain information on the pharmacokinetics of the different uptake routes (oral, inhaled or dermal).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• maximum concentration of enrofloxacin in plasma

  maximum concentration of enrofloxacin in plasma

  change of maximum plasma concentration of enrofloxacin baseline to post dose: 5 minutes (m), 10m, 15m, 20m, 30m, 45m, 1 hour (h) , 1,5 h, 2 h, 3h, 4h, 6h, 8h, 12 h, 24 h.

• Pharmacokinetic assessment of enrofloxacin in urine

  maximum concentration of enrofloxacin in Urine

  change of maximum plasma concentration of enrofloxacin baseline to post dose in urine collection samples : 0-4 hours (h) post, 8-12 hours post, 12-24 hours post

Study Arms (1)

Enrofloxacin

EXPERIMENTAL

enrofloxacin by dermal route, by inhalation, oral adminstration

Drug: Enrofloxacin

Interventions

Enrofloxacin DRUG

dermal application, inhalation rsp. oral administration of Enrofloxacin

Enrofloxacin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests (including a normal coagulation profile), ECGs, vital signs and spirometry.
• Normal spirometry FEV1 (Forced Expiratory Volume in the first second)≥80% of predicted, FEV1/Forced Vital Capacity (FVC) ratio ≥70%) at screening
• Non-smokers for at least one year and with a smoking history of less than 5 pack-years \[number of pack years = (number of cigarettes per day/20) x number of years smoked\].
• Body weight of ≥50 kg and a body mass index BMI (body mass index) of 20 to 24.9 kg/m2
• Height 170 to 195 cm

You may not qualify if:

• Significant history of or current cardiovascular, respiratory (eg asthma, chronic obstructive pulmonary disorder (COPD), bronchiectasis, active Tuberculosis \[TB\]), hepatic, renal, gastrointestinal, endocrine, hematological, autoimmune or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatment; or interfering with the interpretation of data.
• Skin lesions in the area used for the dermal application such as dermographism, dermatitis or eczema.
• Use of prescription or non-prescription drugs (except paracetamol), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) before the first dose of study medication, unless, in the opinion of the investigator, the medication will not interfere with the study procedures or compromise participant safety.
• History of sensitivity to enrofloxacin, ciprofloxacin or any other fluoroquinolones, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months.
• The participant has participated in a clinical trial and has received an investigational product within the following time period before the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)
• Regular use of known drugs of abuse or a positive drugs of abuse test at screening, positive cotinine test at screening
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
• Upper or lower respiratory tract infection 4 weeks prior to screening

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead
• Federal Institute for Occupational Safety and Health (BAuA)/Germany): collaborator

Study Sites (1)

Fraunhofer Institute for Toxicology and Experimental Medicine

Hanover, 30625, Germany

Location

MeSH Terms

Interventions

Enrofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Philipp Badorrek, MD

  Fraunhofer ITEM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects are exposed to 250 µg of enrofloxacin on three different dosing days that are separated by at least 7 days. On the first dosing day, enrofloxacin is administered via the dermal route. On the second dosing day, enrofloxacin is administered via inhalation of 5 mL solution in a concentration of 50 µg/mL by an ultrasonic nebulizer. On the third dosing day, enrofloxacin is administered orally as a 20 mL solution in a concentration of 12.5 µg/mL.

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: July 2, 2018
• Study Start: April 27, 2018
• Primary Completion: June 4, 2018
• Study Completion: August 30, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

DE (1)