Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin TabletPrimary· Pre-dose on Day 1, up to 24 hours post-dose
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
Group
Value
95% CI
Regimen A: Delafloxacin Tablet
15700
± 26.9
Regimen B: Delafloxacin Powder
8120
± 33.9
Maximum Observed Concentration (Cmax) of Delafloxacin PowderSecondary· Pre-dose on Day 1, up to 48 hours post-dose
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL).
Group
Value
95% CI
Regimen B: Delafloxacin Powder
1850
± 33.4
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin PowderSecondary· Pre-dose on Day 1, up to 48 hours post-dose
Blood samples were obtained at protocol-specified timepoints. Results reported as ng\*h/mL.
Group
Value
95% CI
Regimen B: Delafloxacin Powder
8450
± 33.5
Number of Participants Experiencing Treatment-emergent Adverse EventsSecondary· Day 1 through Day 6
An adverse event (AE) was any untoward medical occurrence in a participant that occurred either before dosing or once an investigational medicinal product (IMP) had been administered, including occurrences which were not necessarily caused by or related to that product. Treatment-emergent adverse events were AEs that commenced during/after the first administration of IMP or commenced before first administration of IMP, that is, a pre-dose AE or existing medical condition, but worsened in intensity during exposure to IMP. A summary of all Serious Adverse Events and Other Adverse Events (nonseri
Group
Value
95% CI
Regimen A: Delafloxacin Tablet
2
Regimen B: Delafloxacin Powder
5
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 through Day 6.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will compare the bioavailability of a novel powder for oral suspension formulation of delafloxacin, intended for treatment of community acquired bacterial pneumonia, to that of the licensed delafloxacin oral tablet in healthy adults.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Melinta Therapeutics, Inc.
Last refreshed: 26 September 2025
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/NCT06612255.