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| ID | Type | Description | Link |
|---|---|---|---|
| 1009679 | Other Identifier | Integrated Research Application System (IRAS) | |
| QSC300553 | Other Identifier | Quotient Sciences Study Number |
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Study goals not met
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A then B: Delafloxacin Tablet then Powder | Experimental | Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B). |
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| Regimen B then A: Delafloxacin Powder then Tablet | Experimental | Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A). |
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| Regimen C: Delafloxacin Powder | Experimental | Participants will receive delafloxacin powder in fasted or fed states. |
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| Regimen D (Optional): Delafloxacin Powder | Experimental | Participants will receive delafloxacin powder in fasted or fed states. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delafloxacin | Drug | Delafloxacin tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Pre-dose on Day 1, up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Delafloxacin Powder | Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL). | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Information | Melinta Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Regimen A Then B: Delafloxacin Tablet Then Powder | Participants received delafloxacin tablet in a fasted state (Regimen A), followed by delafloxacin powder in a fasted state (Regimen B). |
| FG001 | Regimen B Then A: Delafloxacin Powder Then Tablet |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2024 | Sep 8, 2025 |
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| Delafloxacin Powder | Drug | Delafloxacin powder for oral suspension formulation |
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Blood samples were obtained at protocol-specified timepoints. Results reported as ng*h/mL. |
| 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. | Day 1 through Day 6 |
Participants received delafloxacin powder in a fasted state (Regimen B), followed by delafloxacin tablet in a fasted state (Regimen A). |
| Receive at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| Washout (4 Days) |
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| Second Intervention |
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Safety Analysis Set: all participants who received any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Regimen A Then B: Delafloxacin Tablet Then Powder | Participants received delafloxacin tablet in a fasted state (Regimen A), followed by delafloxacin powder in a fasted state (Regimen B). |
| BG001 | Regimen B Then A: Delafloxacin Powder Then Tablet | Participants received delafloxacin powder in a fasted state (Regimen B), followed by delafloxacin tablet in a fasted state (Regimen A). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose on Day 1, up to 24 hours post-dose |
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| Secondary | Maximum Observed Concentration (Cmax) of Delafloxacin Powder | Blood samples were obtained at protocol-specified timepoints. Results reported as nanograms/milliliter (ng/mL). | Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Pre-dose on Day 1, up to 48 hours post-dose |
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| Secondary | 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. | Pharmacokinetic Analysis Set: all participants who received at least 1 dose of study drug and who were evaluable for this outcome measure at the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | Pre-dose on Day 1, up to 48 hours post-dose |
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| Secondary | 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. | Safety Analysis Set: all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Day 1 through Day 6 |
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Day 1 through Day 6
All reported safety data based upon the Safety Analysis Set: all participants who received any amount of study drug. 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, safety data were only collected for Regimen A and Regimen B.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Regimen A: Delafloxacin Tablet | Participants received delafloxacin tablet in a fasted state. | 0 | 16 | 0 | 16 | 2 | 16 |
| EG001 | Regimen B: Delafloxacin Powder | Participants received delafloxacin powder in a fasted state. | 0 | 16 | 0 | 16 | 5 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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Following interim review of the pharmacokinetics and safety data, the decision was made to terminate the study early owing to lower-than-expected exposure levels for delafloxacin powder for oral suspension.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Melinta Therapeutics, LLC | 1-844-633-6568 | medinfo@melinta.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2024 | Sep 8, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 15, 2024 | Nov 18, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| C477891 | delafloxacin |
| C405494 | WQ 3034 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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