A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults

Phase 1

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Must agree to adhere to the protocol-specified contraception requirements.
Body mass index of 18.0 to 32.0 kilograms (kg)/meter squared as measured at screening.
Weight ≥50 kg at screening.

Key

Exclusion Criteria

Any history of hypersensitivity to delafloxacin or any other fluoroquinolones or previous history of tendon disorders related to fluoroquinolone administration.
History of clinically significant cardiovascular, renal, hepatic, respiratory, or particularly gastrointestinal disease.
Participant has a medical condition that may adversely affect taste or smell activity including but not limited to mouth ulcers, significant gum disease, and respiratory and/or sinus infection or cold.
Clinically significant abnormal clinical chemistry, hematology or urinalysis as judged by the Investigator. Participants with Gilbert's Syndrome are not allowed.
Participants who do not agree to eat a high-fat breakfast.

Note: Other inclusion/exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Regimen A then B: Delafloxacin Tablet then Powder	Delafloxacin	Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
Regimen A then B: Delafloxacin Tablet then Powder	Delafloxacin Powder	Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).
Regimen B then A: Delafloxacin Powder then Tablet	Delafloxacin	Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
Regimen B then A: Delafloxacin Powder then Tablet	Delafloxacin Powder	Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).
Regimen C: Delafloxacin Powder	Delafloxacin Powder	Participants will receive delafloxacin powder in fasted or fed states.
Regimen D (Optional): Delafloxacin Powder	Delafloxacin Powder	Participants will receive delafloxacin powder in fasted or fed states.

Primary Outcome Measures

Name	Time	Method
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	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).

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of Delafloxacin Powder	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).
Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder	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.
Number of Participants Experiencing Treatment-emergent Adverse Events	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 (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.