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

A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Delafloxacin; Drug: Delafloxacin Powder

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Ruddington, Nottingham, United Kingdom, NG11 6JS
      • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regimen C: Delafloxacin Powder; Participants will receive delafloxacin powder in fasted or fed states.	Drug: Delafloxacin Powder; Delafloxacin powder for oral suspension formulation
Experimental: Regimen D (Optional): Delafloxacin Powder; Participants will receive delafloxacin powder in fasted or fed states.	Drug: Delafloxacin Powder; Delafloxacin powder for oral suspension formulation
Experimental: Regimen A then B: Delafloxacin Tablet then Powder; Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).	Drug: Delafloxacin; Delafloxacin tablet; Other Names: RX-3341; Baxdela; Quofeni; Delabaxi; ABT-492; ABT-319492; WQ-3034; Drug: Delafloxacin Powder; Delafloxacin powder for oral suspension formulation
Experimental: Regimen B then A: Delafloxacin Powder then Tablet; Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).	Drug: Delafloxacin; Delafloxacin tablet; Other Names: RX-3341; Baxdela; Quofeni; Delabaxi; ABT-492; ABT-319492; WQ-3034; Drug: Delafloxacin Powder; Delafloxacin powder for oral suspension formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Melinta Therapeutics, Inc.
• Collaborators: Biomedical Advanced Research and Development Authority
• Investigators: Study Director: Medical Information, Melinta Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Actual): September 11, 2024
• Study Completion (Actual): September 11, 2024

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 26, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Bioavailability; Delafloxacin; Baxdela; BARDA; Taste-masked
• Additional Relevant MeSH Terms: Anti-Bacterial Agents; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; delafloxacin; WQ 3034
• Other Study ID Numbers: ML-DEL-101-3727-1; 1009679 (Other Identifier: Integrated Research Application System (IRAS)); QSC300553 (Other Identifier: Quotient Sciences Study Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No