Safety and TolerabilityPhase 1NCT01907867
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
A Phase 1 study testing Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days in people with Safety and Tolerability, run by MerLion Pharmaceuticals GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability
- What is being tested?
- Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Feb 2012
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- ≥48 kg and ≤100 kg;
- 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:
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- A woman of childbearing potential is defined as any female subject who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as women over the age of 50 who have been amenorrheic for at least 12 consecutive months);
- Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier method (diaphragm, condoms, spermicides) to prevent pregnancy, or whose partner is sterile (e.g. vasectomy) should be considered to be of childbearing potential;
- 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;
- 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.
Who cannot join
- 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;
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- 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;
- Known hypersensitivity to finafloxacin or to any other fluoroquinolone;
- Donated any blood, plasma, or platelets in the 3 months prior to enrollment or on more than 2 occasions within the 12 months preceding the first dose of study drug;
- Known history of tendon rupture or tendonitis;
- A positive urine drug screen or breath alcohol test result at Screening or enrollment;
- Known to have viral hepatitis, or are positive for the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody, or are positive for Human Immunodeficiency Virus (HIV) antibodies;
- Clinically significant abnormal laboratory values at Screening or enrollment;
- Unable or unwilling, in the judgment of the Investigator, to comply with the protocol;
- An employee of the Investigator or study site with direct involvement in the proposed study or other studies under the direction of the Investigator or study site, or a family member of the site employee or the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin After Single and Multiple Doses Administered Orally in Healthy Volunteers
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.
- Conditions
- Safety and Tolerability
- Being tested
- Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 daysDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Day 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 3 hours after the oral dose.
Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose).
Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 6 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. Receives: Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days |
| Cohort 2 | Experimental | Day 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 8 hours after the oral dose.
Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose).
Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose.
Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 12 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. Receives: Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days |
| Cohort 3 | Experimental | Day 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 12 hours after the oral dose.
Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose).
Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose.
Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 24 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. Receives: Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of orally administered finafloxacin in healthy subjects.
The assessment of safety will be based primarily on the frequency of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, and 12-lead ECGs. Other safety data will be summarized as appropriate. The data will be presented in descriptive manner.
Measured: Day 3
Secondary outcomes (2)
Pharmacokinetic (PK) profile in plasma and epithelial lining fluid (ELF)
To assess the pharmacokinetic (PK) profile in plasma and epithelial lining fluid (ELF) of finafloxacin after single and multiple doses administered orally in healthy subjects;
Measured: Day 3
Comparison of bronchial ELF PK profiles with alveolar ELF PK profiles.
To compare the bronchial ELF PK profiles obtained by bronchoscopic microsampling (BMS) techniques to alveolar ELF PK profiles obtained by bronchoalveolar lavage (BAL).
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and TolerabilityStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark H. Gottfried, MD, Principal investigator, Pulmonary Associates, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907867
- Sponsor's protocol ID
- FINA-008
- Status last verified
- Feb 2017
- First submitted
- 17 Jul 2013
- Last updated
- 20 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin After Single and Multiple Doses Administered Orally in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01907867
- Acronym / sponsor ID
- FINA-008
- Conditions
- Safety and Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 daysDay 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 3 hours after the oral dose. Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose). Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 6 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. |
| Cohort 2 | Experimental | Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 daysDay 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 8 hours after the oral dose. Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose). Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 12 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. |
| Cohort 3 | Experimental | Drug: Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 daysDay 1: Finafloxacin 800 mg will be administered as an oral dose once in the morning (first dose). Subjects will have plasma PK samples drawn at specified times around the first dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 12 hours after the oral dose. Day 2: Finafloxacin 800 mg will be administered as an oral dose once in the morning (second dose). Day 3: Finafloxacin 800 mg will be administered as an oral dose once in the morning (third dose). Subjects will have plasma PK samples drawn at specified times around the third dose. Bronchoscopic microsampling will be performed to obtain bronchial ELF samples in triplicate at 24 hours after the oral dose, followed immediately by BAL to obtain alveolar ELF samples. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
- ≥48 kg and ≤100 kg;
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
To assess the safety and tolerability of orally administered finafloxacin in healthy subjects.
Time frame: Day 3
The assessment of safety will be based primarily on the frequency of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, and 12-lead ECGs. Other safety data will be summarized as appropriate. The data will be presented in descriptive manner.
2 secondary outcomes
Pharmacokinetic (PK) profile in plasma and epithelial lining fluid (ELF)
Time frame: Day 3
Comparison of bronchial ELF PK profiles with alveolar ELF PK profiles.
Time frame: Day 3
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 20 Feb 2017.
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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.
Mark H. Gottfried, MD principal investigator
Pulmonary Associates, PA
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 Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days in people with Safety and Tolerability, 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 11 inclusion and 16 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 20 Feb 2017. 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?
To assess the safety and tolerability of orally administered finafloxacin in healthy subjects. (time frame: Day 3). 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 20 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.