Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects (NCT01910883) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
United Kingdom58 participantsStarted 2010-09
Plain-language summary
This is the first time finafloxacin was administered to humans intravenously. The principal aim of this study was to obtain safety and tolerability data when finafloxacin was administered intravenously as single and multiple doses to healthy subjects.
Who can participate
Age range
18 Years – 65 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:
* Subjects will be males or females of any ethnic origin between 18 and 65 years of age and with a body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
* Female subjects must be of non-childbearing potential, and are defined as follows: Female subjects 50 years of age or less must be surgically sterile or post-menopausal (defined as at least two years post cessation of menses and/or follicular stimulating hormone \>40 mIU/mL and serum oestradiol \<110 pmol/L).
Female subjects of more than 51 years of age must be surgically sterile or post-menopausal (defined by a value of follicular stimulating hormone \>40 mIU/mL and no spontaneous menstruation for at least one year before the first dose).
* Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations.
* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
Exclusion Criteria:
* Male subjects who are not willing, or whose partners are not willing, to use appropriate contraception (such as condom with spermicidal foam/gel/film/cream/suppository) from the time of the first dose until 3 months after the final dosing occasion.
* Subjects who have received any prescribed systemic or topical medication within 14 days (or corticosteroids within 4 weeks) of the first dose administration (for female subjects, stable hormone replacement …
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.