Pharmacokinetic and Tolerability of FinafloxacinPhase 1NCT01904162
Effect of Age and Gender on the PK and Tolerability of Finafloxacin
A Phase 1 study testing 400 mg finafloxacin (2 x 200 mg tablets) in people with Pharmacokinetic and Tolerability of Finafloxacin, run by MerLion Pharmaceuticals GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetic and Tolerability of Finafloxacin
- What is being tested?
- 400 mg finafloxacin (2 x 200 mg tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Subject with any clinically significant illness 3 months before the study.
- Subject who had donated blood or plasma during the previous 56 days prior to dosing.
- Subject who was unlikely to comply with the clinical study protocol.
- Subject who was a member of the clinical site or Sponsor personnel or their immediate family, defined as spouse, parent, sibling, child, grandparent, or grandchild.
- Any other condition that, in the opinion of the PI, precluded participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Celerion (formerly MDS Pharmaservices)
Tempe, Arizona, 85283
About this study
Official title: Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin-HCL in Healthy Volunteers
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.
- Being tested
- 400 mg finafloxacin (2 x 200 mg tablets)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400 mg finafloxacin (2 x 200 mg tablets)Drug
| Study group | Role | What they receive |
|---|---|---|
| healthy young adult males | Experimental | healthy young adult males receiving 400 mg finafloxacin single dose Receives: Drug: 400 mg finafloxacin (2 x 200 mg tablets) |
| healthy young adult females | Experimental | healthy young adult females receiving 400 mg finafloxacin single dose Receives: Drug: 400 mg finafloxacin (2 x 200 mg tablets) |
| healthy elderly adult males | Experimental | healthy elderly adult males receiving 400 mg finafloxacin single dose Receives: Drug: 400 mg finafloxacin (2 x 200 mg tablets) |
| healthy elderly adult females | Experimental | healthy elderly adult females receiving 400 mg finafloxacin single dose Receives: Drug: 400 mg finafloxacin (2 x 200 mg tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
Safety and tolerability
- The number and severity of treatment-emergent adverse events (TEAEs) following single doses of finafloxacin for each population in the study
- Changes from baseline for each population for safety clinical laboratory parameters, electrocardiographs, vital signs, and physical examinations
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startFeb 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetic and Tolerability of FinafloxacinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904162
- Sponsor's protocol ID
- FINA-005
- Other IDs
- AA83723
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Age and Gender on the Pharmacokinetics and Tolerability of a Single Dose of Finafloxacin-HCL in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01904162
- Acronym / sponsor ID
- FINA-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| healthy young adult males | Experimental | Drug: 400 mg finafloxacin (2 x 200 mg tablets)healthy young adult males receiving 400 mg finafloxacin single dose |
| healthy young adult females | Experimental | Drug: 400 mg finafloxacin (2 x 200 mg tablets)healthy young adult females receiving 400 mg finafloxacin single dose |
| healthy elderly adult males | Experimental | Drug: 400 mg finafloxacin (2 x 200 mg tablets)healthy elderly adult males receiving 400 mg finafloxacin single dose |
| healthy elderly adult females | Experimental | Drug: 400 mg finafloxacin (2 x 200 mg tablets)healthy elderly adult females receiving 400 mg finafloxacin single dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
Pharmacokinetic
Time frame: Day 1
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.
1 secondary outcome
Safety and tolerability
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 400 mg finafloxacin (2 x 200 mg tablets) in people with Pharmacokinetic and Tolerability of Finafloxacin, run by MerLion Pharmaceuticals GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.