HealthyPhase 1NCT01910883

Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

A Phase 1 study testing Finafloxacin i.v. solution 200 mg, Finafloxacin i.v. solution 400 mg and Finafloxacin i.v. solution 600 mg in people with Healthy, run by MerLion Pharmaceuticals GmbH at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Finafloxacin i.v. solution 200 mg, Finafloxacin i.v. solution 400 mg and Finafloxacin i.v. solution 600 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2010to Mar 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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 therapy is acceptable) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.
Subjects who have donated any blood, plasma or platelets in the 3 months prior to randomisation or who have made donations on more than two occasions within the 12 months preceding the first dose administration.

Show all 22Show fewer

Subjects with a significant history of drug allergy as determined by the Investigator.
Subjects with a current or history of allergy to antibiotics as determined by the Investigator.
Subjects who have out of range values for Liver Function Tests.
Subjects with non-haemolytic bilirubinaemia (Gilbert's syndrome).
Subjects who have any clinically significant allergic disease (excluding non-active hayfever) as determined by the Investigator.
Subjects who have a supine blood pressure and supine pulse rate higher than 140/90 mmHg and 100 beats per minute (bpm), respectively, or lower than 90/50 mmHg and 40 bpm, respectively, confirmed by a repeat assessment.
Subjects who consume more than 28 units (males) or more than 21 units (females) of alcohol per week or who have a significant history of alcoholism or drug/chemical abuse as determined by the Investigator (1 unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
Subjects with a positive urine drug screen or alcohol breath test result at screening or first admission.
Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.
Subjects with, or with a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorders as determined by the Investigator.
Subjects with a history of tendon rupture or tendonitis.
Subjects who have had a clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
19. Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen (HBsAg) or hepatitis C antibody, or who have a positive result to the test for HIV antibodies.
Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as QTcB interval >450 msec (male) or greater than 470 msec (female), 2nd or 3rd degree Atrioventricular block, complete left bundle branch block, complete right bundle branch block or Wolff-Parkinson-White Syndrome, defined as PR<110 msec, confirmed by a repeat ECG.
Subjects who have previously taken part in or withdrawn from this study.
Subjects who, in the opinion of the Investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit Ltd
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: Finafloxacin - A Double-blind, Placebo-controlled, Randomised, Dose-escalating, Crossover Study to Determine the Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects

Conditions: Healthy
Being tested: Finafloxacin i.v. solution 200 mg, Finafloxacin i.v. solution 400 mg, Finafloxacin i.v. solution 600 mg, Finafloxacin i.v. solution 800 mg, Finafloxacin i.v. solution 1000 mg
Keywords: Safety, Tolerability, Pharmacokinetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Finafloxacin i.v. solution 200 mgDrug
Finafloxacin i.v. solution 400 mgDrug
Finafloxacin i.v. solution 600 mgDrug
Finafloxacin i.v. solution 800 mgDrug
Finafloxacin i.v. solution 1000 mgDrug
Placebo i.v. solutionDrug

Study groups in NCT01910883
Study group	Role	What they receive
Group 1	Experimental	Single doses of 200, 400 and 600 mg finafloxacin i.v. Receives: Drug: Finafloxacin i.v. solution 200 mg; Drug: Finafloxacin i.v. solution 400 mg; Drug: Finafloxacin i.v. solution 600 mg; Drug: Placebo i.v. solution
Group 2	Experimental	Single doses of 800 and 1000 mg finafloxacin i.v. Receives: Drug: Finafloxacin i.v. solution 800 mg; Drug: Finafloxacin i.v. solution 1000 mg; Drug: Placebo i.v. solution
Group 3	Experimental	Multiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 600 mg i.v. Receives: Drug: Finafloxacin i.v. solution 600 mg; Drug: Placebo i.v. solution
Group 4	Experimental	Multiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 600 mg i.v. (additional to Group 3) Receives: Drug: Finafloxacin i.v. solution 600 mg; Drug: Placebo i.v. solution
Group 5	Experimental	Multiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 800 mg i.v. Receives: Drug: Finafloxacin i.v. solution 400 mg; Drug: Finafloxacin i.v. solution 800 mg; Drug: Placebo i.v. solution
Group 6	Experimental	Multiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 1000 mg i.v. Receives: Drug: Finafloxacin i.v. solution 1000 mg; Drug: Placebo i.v. solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety
The primary objective was to evaluate the safety and tolerability of single and multiple intravenous (IV) doses of finafloxacin in healthy subjects.
The safety evaluation includes the descriptive display and analysis of adverse events after single and multiple doses for 7 days of intravenously administered finafloxacin.
The frequency of adverse events is evaluated for all casualties and for drug related adverse events. Comparisons between the placebo and verum groups are provided in descriptive manner.
In addition the evaluation of clinical laboratory data, vital signs, electrocardiography data, physical examination, local tolerability is provided.
Measured: 1 to 7 days

Secondary outcomes (1)

Pharmacokinetic parameters of finafloxacin in plasma and urine samples from healthy subjects using non compartmental procedures
The pharmacokinetic parameters determined for single dose are:
AUC, Cmax, tlast, t½, CL, VZ, VSS, amount of drug excreted in urine, fraction of dose excreted in urine, renal clearance.
The pharmacokinetic parameters determined for multiple dose are:
AUC, Cmax, tmax, t½, observed accumulation ratio, predicted accumulation ratio, linearity ratio, CL, VZ, VSS, amount of drug excreted in urine, fraction of dose excreted in urine, renal clearance.
In addition, dose and body weight normalised values (norm) for AUC 0-τ, AUC0- tlast, AUC and Cmax were determined by dividing the original pharmacokinetic parameter by dose per kg body weight. Body weight normalised values [norm] for CL, VZ and CLR were calculated by dividing the original pharmacokinetic parameter by body weight.
Measured: 1 to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Mar 2012

First posted30 Jul 2013 (estimated)
Study startSep 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01910883
Sponsor's protocol ID: FINA-006
Other IDs: 2010-021555-26
Status last verified: Jul 2013
First submitted: 17 Jul 2013
Last updated: 30 Jul 2013
Results posted: No
Data monitoring committee: No

Publications

Taubert M, Chiesa J, Luckermann M, Fischer C, Dalhoff A, Fuhr U. Pharmacokinetics of Intravenous Finafloxacin in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e01122-17. doi: 10.1128/AAC.01122-17. Print 2017 Oct.
PubMed 28784673

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Finafloxacin - A Double-blind, Placebo-controlled, Randomised, Dose-escalating, Crossover Study to Determine the Safety and Tolerability of Single and Multiple Intravenous Doses of Finafloxacin in Healthy Subjects
ClinicalTrials.gov ID: NCT01910883
Acronym / sponsor ID: FINA-006
Conditions: Healthy
Keywords: Safety, Tolerability, Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: MerLion Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 30 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1	Experimental	Drug: Finafloxacin i.v. solution 200 mg, Drug: Finafloxacin i.v. solution 400 mg, Drug: Finafloxacin i.v. solution 600 mg, Drug: Placebo i.v. solutionSingle doses of 200, 400 and 600 mg finafloxacin i.v.
Group 2	Experimental	Drug: Finafloxacin i.v. solution 800 mg, Drug: Finafloxacin i.v. solution 1000 mg, Drug: Placebo i.v. solutionSingle doses of 800 and 1000 mg finafloxacin i.v.
Group 3	Experimental	Drug: Finafloxacin i.v. solution 600 mg, Drug: Placebo i.v. solutionMultiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 600 mg i.v.
Group 4	Experimental	Drug: Finafloxacin i.v. solution 600 mg, Drug: Placebo i.v. solutionMultiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 600 mg i.v. (additional to Group 3)
Group 5	Experimental	Drug: Finafloxacin i.v. solution 400 mg, Drug: Finafloxacin i.v. solution 800 mg, Drug: Placebo i.v. solutionMultiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 800 mg i.v.
Group 6	Experimental	Drug: Finafloxacin i.v. solution 1000 mg, Drug: Placebo i.v. solutionMultiple doses of finafloxacin once daily (o.d.) for 7 days at dose levels of 1000 mg i.v.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (22 listed)

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 therapy is acceptable) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration (with the exception of vitamin/mineral supplements) unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise safety.
Subjects who are still participating in a clinical study (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug in the past 3 months.

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 i.v. solution 200 mg	Drug	Group 1
Finafloxacin i.v. solution 400 mg	Drug	Group 1, Group 5
Finafloxacin i.v. solution 600 mg	Drug	Group 1, Group 3, Group 4
Finafloxacin i.v. solution 800 mg	Drug	Group 2, Group 5
Finafloxacin i.v. solution 1000 mg	Drug	Group 2, Group 6
Placebo i.v. solution	Drug	Group 1, Group 2, Group 3, Group 4, Group 5, Group 6

Primary outcome

Safety
Time frame: 1 to 7 days
The primary objective was to evaluate the safety and tolerability of single and multiple intravenous (IV) doses of finafloxacin in healthy subjects. The safety evaluation includes the descriptive display and analysis of adverse events after single and multiple doses for 7 days of intravenously administered finafloxacin. The frequency of adverse events is evaluated for all casualties and for drug related adverse events. Comparisons between the placebo and verum groups are provided in descriptive manner. In addition the evaluation of clinical laboratory data, vital signs, electrocardiography data, physical examination, local tolerability is provided.

1 secondary outcome

Pharmacokinetic parameters of finafloxacin in plasma and urine samples from healthy subjects using non compartmental procedures
Time frame: 1 to 7 days

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 30 Jul 2013.
Derived from this study: PubMed 28784673Taubert M, Chiesa J, Luckermann M, Fischer C, Dalhoff A, Fuhr U. Pharmacokinetics of Intravenous Finafloxacin in Healthy Volunteers. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e01122-17. doi: 10.1128/AAC.01122-17. Print 2017 Oct.

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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.

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?

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 5 inclusion and 22 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 30 Jul 2013. 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 Kingdom. 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?

Safety (time frame: 1 to 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01910883, which also lists 1 linked publication.

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 30 Jul 2013.