Effect of Age and Gender on the PK and Tolerability of Finafloxacin

NCT01904162 | Completed Phase 1

• 2 other identifiers: FINA-005AA83723
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetic and Tolerability of Finafloxacin

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic

  The primary PK endpoints of the study were the 90% confidence interval (CI) for the ratio of the population geometric means of the PK parameters AUC0-t, AUC0-24, AUC0-inf, and Cmax in plasma and the 90% CI for the ratio of the population geometric means of the PK parameters CumAe0-24 and Rmax in urine.

  Day 1

Secondary Outcomes (1)

• Safety and tolerability

  Day 1

Study Arms (4)

healthy young adult males

EXPERIMENTAL

healthy young adult males receiving 400 mg finafloxacin single dose

Drug: 400 mg finafloxacin (2 x 200 mg tablets)

healthy young adult females

EXPERIMENTAL

healthy young adult females receiving 400 mg finafloxacin single dose

Drug: 400 mg finafloxacin (2 x 200 mg tablets)

healthy elderly adult males

EXPERIMENTAL

healthy elderly adult males receiving 400 mg finafloxacin single dose

Drug: 400 mg finafloxacin (2 x 200 mg tablets)

healthy elderly adult females

EXPERIMENTAL

healthy elderly adult females receiving 400 mg finafloxacin single dose

Drug: 400 mg finafloxacin (2 x 200 mg tablets)

Interventions

400 mg finafloxacin (2 x 200 mg tablets) DRUG

healthy elderly adult females; healthy elderly adult males; healthy young adult females; healthy young adult males

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) for a minimum of 6 months.
• Intrauterine device (IUD) in place for at least 3 months.
• Barrier methods (condom and diaphragm) plus spermicide for at least 14 days prior to the first dose and throughout the study.
• Surgical sterilization of the partner (vasectomy for 6 months minimum).
• Hormonal contraceptives for at least 3 months prior to the first dose of the study and throughout the study.
• 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:
• Bilateral tubal ligation.
• Hysterectomy.
• Hysterectomy with unilateral or bilateral oophorectomy.
• Bilateral oophorectomy.

You may not qualify if:

• Subject with psychiatric, neurological, or behavioral disorders that may have interfered with the conduct or interpretation of the study.
• Subject with a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or hematological disorders that were capable of significantly altering the absorption, metabolism, or elimination of drugs, or were considered a risk with the study medication or could have interfered with the interpretation of data.
• Subject who had an abnormality in the 12-lead ECG that, in the opinion of the PI, increased the risks associated with participating in the study.
• Subject with clinically relevant abnormal laboratory data or vital signs at screening, or any abnormal laboratory value which, in the opinion of the PI, could have interfered with the assessment of safety.
• Subject with exposure to any investigational drug within 30 days prior to screening.
• Subject with a known hypersensitivity or other contraindication to the use of fluoroquinolones.
• Subject with a history of tendon rupture or tendonitis.
• Subject who received corticosteroid therapy in the 4 weeks prior to study drug administration.
• Subject with prior participation in a finafloxacin investigational study.
• Subject who had current diagnosis or known history of drug and/or alcohol abuse.
• Subject who smoked \> 10 cigarettes per day and was unable or unwilling to refrain from nicotine during study confinement.
• Subject who received any drugs known to strongly inhibit or induce any of the enzymes within the cytochrome P-450 (CYP) system within 30 days prior to the first dose.
• Subject who had exposure to any medication (with the exception of hormone replacement therapy \[HRT\] for the elderly subjects), including over-the-counter (OTC) medications, 7 days prior to dosing.
• Subject who had exposure to antacid medication 24 hours prior to study drug administration until collection of the last PK sample.
• Subject who had consumed grapefruit 10 days prior to study drug administration until collection of the last PK sample.

Sponsors & Collaborators

• MerLion Pharmaceuticals GmbH: lead

Study Sites (1)

Celerion (formerly MDS Pharmaservices)

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

finafloxacin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: February 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: March 13, 2024

Record last verified: 2013-07

Locations

US (1)