Evaluation of Innovative Tools in Development of Antibiotics

Medical University of Vienna

Status and phase

Completed

Phase 1

Conditions

Pneumonia

Treatments

Drug: Ciprofloxacin

Drug: Imipenem

Study type

Interventional

Funder types

Other

Identifiers

NCT03177720

ELF Cipro

Details and patient eligibility

About

The investigators will determine the difference of pharmacokinetics of ciprofloxacin and imipenem between healthy volunteers and intensive care patients suffering from pneumonia in plasma and at the target site - lung - using bronchoalveolar lavage. As additional aspect the feasibility of combining microdosing of C14 ciprofloxacin with microdialysis, saliva sampling and bronchoalveolar lavage is studied by comparing pharmacokinetics of microdose and macrodose.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male subjects aged 18 to 55 years
Good state of health (mentally and physically)
Body mass index within a range of 18 to 28kg/m2 inclusive.
Non-Smoker
A signed and dated written informed consent form.
The subject is able to understand and willing to comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
Negative serology (human immunodeficiency virus, hepatitis B-AG and C-AB) at screening.
Vital signs should be within the following ranges:
Oral or tympanic temperature between 35 and 37.5°C.
Systolic blood pressure, 90-140 mmHg.
Diastolic blood pressure, 50-90 mmHg.
Pulse rate, 50-90 bpm.

Exclusion criteria

Any acute or chronic illness or clinically relevant (Investigator's judgement) abnormality identified on the screening medical assessment, laboratory tests or ECG, unless in the opinion of the Investigator it will not interfere with the study procedures, affect the outcome of the study or compromise the safety of the subject.
All subjects with known seizure disorder, with the exception of a febrile seizure in childhood
Use of prescription or non-prescription drugs within 7 days or 10 times the elimination half-life (whichever is longer) prior to the first dose of study medication.
Any intake of grapefruit juice within 1 week prior to the first dose.
Allergies (except for mild forms of hay fever), a history of hypersensitivity reactions including psychological or neurological symptoms or signs, or anaphylactic shock following administration of any medicine.
Allergy to or any contraindication against the active or inactive ingredients in the study medication (ciprofloxacin, imipenem, cilastatin, propofol, midazolam, remifentanil, xylocain, and sevoflurane) and radioactive labelling with 14C.
Smoker
Alcohol or drug abuse
Participation in a trial with any drug within 30 days or five half-lives (whichever is longer) before the start of the study.
Donation of blood within a period of 4 weeks prior to dosing.
Creatinine clearance ≤70mL/min/1.73m3
Any other reason that the Investigator considers to make the subject unsuitable to participate.