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About
Previous clinical studies have indicated that finafloxacin is well-tolerated with few treatment-related adverse events. As a part of the clinical development of finafloxacin, other PK studies are required to determine the effect of other variables on the PK profile of finafloxacin. This study aims to determine the effect of age and gender on the pharmacokinetic profile of finafloxacin.
Enrollment
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Inclusion criteria
Healthy adult male and/or female, 18 to 35 years of age (inclusive), or 65 years or over(≥ 65 years).
Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
No clinically significant abnormal findings, as judged by the Principal Investigator (PI), on the physical examination, ECG, medical history, or clinical laboratory results during screening.
Negative screen for human immunodeficiency virus (HIV), hepatitis B, C and/or positive hepatitis B surface antigen (HBsAg), and anti-Hepatitis C virus (HCV) antibodies.
Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods:
Females of non-childbearing potential were either postmenopausal for at least 2 consecutive years prior to Day 1, with a follicle-stimulating hormone (FSH) level > 40 IU/mL or had undergone one of the following sterilization procedures at least 6 months prior to Day 1:
Male subjects were either sexually inactive (abstinent) or using a barrier method for 14 days prior to the first dose and throughout the study.
In addition, male subjects and female subjects of childbearing potential were advised to remain sexually inactive or to keep the same birth control method for at least 30 days in the case of females and 90 days in the case of males, following the last dose. Male subjects were additionally advised not to donate sperm for 90 days following the last dose.
Was able to understand and willing to sign an ICF.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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