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

Phase 1TerminatedNCT06612255

Melinta Therapeutics, Inc.16 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

DelafloxacinDRUG

Delafloxacin tablet

Delafloxacin PowderDRUG

Delafloxacin powder for oral suspension formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences

Ruddington, Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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