Trial · NCT01907867
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
NCT01907867, Phase 1, Completed, MerLion Pharmaceuticals GmbH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin. Trials, record NCT01907867. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01907867
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
- NCT number
- NCT01907867
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 18 participants, actual
- Lead sponsor
- MerLion Pharmaceuticals GmbH
- Conditions
- Safety and Tolerability
- Interventions
- Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days
- First posted
- 2013-07-25
- Last updated
- 2017-02-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the safety and tolerability of orally administered finafloxacin in healthy subjects. | 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. |
| Secondary | Pharmacokinetic (PK) profile in plasma and epithelial lining fluid (ELF) | Day 3 | 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; |
| Secondary | Comparison of bronchial ELF PK profiles with alveolar ELF PK profiles. | Day 3 | To compare the bronchial ELF PK profiles obtained by bronchoscopic microsampling (BMS) techniques to alveolar ELF PK profiles obtained by bronchoalveolar lavage (BAL). |
| Other | Intracellular concentrations of finafloxacin in alveolar macrophages (AMs). | Day 3 | To assess the intracellular concentrations of finafloxacin as measured in alveolar macrophages (AMs) obtained by BAL. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01907867
GET https://conductscience.org/api/trials/v1/NCT01907867/registered