A Phase 1 interventional study of Delafloxacin and Delafloxacin Powder in Healthy, sponsored by Melinta Therapeutics, Inc.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Melinta Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
Melinta Therapeutics, Inc. is the lead sponsor of 30 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
Drug: Delafloxacin · Drug: Delafloxacin Powder
Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
Drug: Delafloxacin · Drug: Delafloxacin Powder
Participants will receive delafloxacin powder in fasted or fed states.
Drug: Delafloxacin Powder
Participants will receive delafloxacin powder in fasted or fed states.
Drug: Delafloxacin Powder
Delafloxacin tablet
Also known as: Baxdela, Quofeni, Delabaxi, RX-3341, ABT-492, ABT-319492, WQ-3034
Delafloxacin powder for oral suspension formulation
Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
Time frame: Pre-dose on Day 1, up to 24 hours post-dose
Maximum Observed Concentration (Cmax) of Delafloxacin Powder
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL).
Time frame: Pre-dose on Day 1, up to 48 hours post-dose
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder
Blood samples were obtained at protocol-specified timepoints. Results reported as ng\*h/mL.
Time frame: Pre-dose on Day 1, up to 48 hours post-dose
Number of Participants Experiencing Treatment-emergent Adverse Events
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 (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Day 1 through Day 6
During the interim decision meeting following dosing of Regimen A and Regimen B, it was decided not to proceed with Regimen C and Regimen D of the study, and subsequently the decision was made to terminate the study early. Therefore, data were only collected for Regimen A and Regimen B.
| Milestone | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet |
|---|---|---|
| Started | 8 | 8 |
| Receive at least 1 dose of study drug | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet |
|---|---|---|
| Started | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
| Milestone | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet |
|---|---|---|
| Started | 8 | 8 |
| Receive at least 1 dose of study drug | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 0 | 0 |
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms\*hour/milliliter (ng\*h/mL).
| ng*h/mL | Regimen A: Delafloxacin Tablet | Regimen B: Delafloxacin Powder |
|---|---|---|
| Area Under the Mean Concentration Time Curve From Time 0 to 24 Hours Post-dose (AUC0-24) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet | 15700 ± 26.9 | 8120 ± 33.9 |
Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL).
| ng/mL | Regimen B: Delafloxacin Powder |
|---|---|
| Maximum Observed Concentration (Cmax) of Delafloxacin Powder | 1850 ± 33.4 |
Blood samples were obtained at protocol-specified timepoints. Results reported as ng\*h/mL.
| ng*h/mL | Regimen B: Delafloxacin Powder |
|---|---|
| Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder | 8450 ± 33.5 |
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 (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Regimen A: Delafloxacin Tablet | Regimen B: Delafloxacin Powder |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | 2 | 5 |
Collected over Day 1 through Day 6. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Regimen A: Delafloxacin Tablet | 0/16 (0%) | 0/16 (0%) | 2/16 (12.5%) |
| Regimen B: Delafloxacin Powder | 0/16 (0%) | 0/16 (0%) | 5/16 (31.3%) |
| Event | Regimen A: Delafloxacin Tablet | Regimen B: Delafloxacin Powder |
|---|---|---|
| HeadacheNervous system disorders | 0/16 | 2/16 |
| DiarrhoeaGastrointestinal disorders | 0/16 | 2/16 |
| DizzinessNervous system disorders | 1/16 | 0/16 |
| Catheter site painGeneral disorders | 1/16 | 0/16 |
| FatigueGeneral disorders | 0/16 | 1/16 |
| Seasonal allergyImmune system disorders | 0/16 | 1/16 |
| Dry skinSkin and subcutaneous tissue disorders | 0/16 | 1/16 |
Safety Analysis Set: all participants who received any amount of study drug.
| Age, Continuous(years) | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet | Total |
|---|---|---|---|
| Mean | 35.3 ± 10.3 | 36.0 ± 14.4 | 35.6 ± 12.1 |
| Sex: Female, Male(Participants) | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 5 | 5 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 8 | 16 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Regimen A Then B: Delafloxacin Tablet Then Powder | Regimen B Then A: Delafloxacin Powder Then Tablet | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 7 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 1 | 4 |
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This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Melinta Therapeutics, Inc.