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NCT01907867
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
Phase 1 trial testing Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days in Safety and Tolerability in 18 participants. Completed in 1 February 2012.
1 February 2012
Quick facts
| Lead sponsor | MerLion Pharmaceuticals GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 1 January 2012 |
| Primary completion | 1 February 2012 |
| Estimated completion | 1 February 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days — full drug profile →
Conditions studied
- Safety and Tolerability — all drugs for Safety and Tolerability →
Sponsor
MerLion Pharmaceuticals GmbH — full company profile →
Who can join
Adults 18 to 55, any sex, with Safety and Tolerability. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01907867
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
- NCT07098663 — Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01907867 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by MerLion Pharmaceuticals GmbH
- Last refreshed: 17 February 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01907867.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing