Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin (NCT01907867) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
United States18 participantsStarted 2012-01
Plain-language summary
This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to provide written informed consent;
. Age ≥18 years and ≤55 years;
. Male or female healthy volunteer;
. Body mass index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2 and a body weight
. Women of childbearing potential must have a negative urine pregnancy test confirmed at Screening before study enrollment, must not be breastfeeding, and must use an effective method of contraception for at least 1 month before enrollment and through 3 months following completion of the study:
. If a male subject's sexual partner is of childbearing potential, the male subject must acknowledge that they are using an acceptable method of contraception (defined above) from the first dose of study drug until 3 months from last dosing occasion to prevent pregnancy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety and tolerability of orally administered finafloxacin in healthy subjects.
. Expectation, in the judgment of the Investigator, that the subject will complete all study activities; and
. Willing to comply with all the study activities and procedures throughout the duration of the study.
Exclusion criteria
. Known chronic medical conditions, including any respiratory condition such as asthma or chronic obstructive pulmonary disease, or cardiovascular conditions such as hypertension or coronary artery disease;
. Prolongation of corrected QT interval (QTcB) at rest, where the mean QTcB interval is \>500 msec based on triplicate ECG at Screening;
. Use of tobacco products within 6 months of Screening;
. Women who are pregnant or breastfeeding;
. Receipt of any investigational medication during the last month (30 days or 5 half-lives, whichever is longer) prior to enrollment;
. Prior exposure to finafloxacin;
. Use of any concomitant medication (including over-the-counter drugs, vitamins, and antacids) within 7 days prior to study drug administration and during the study (acetaminophen is allowed);
. Any disorder that may interfere with the evaluation of study drug;