Clinical trial NCT06612255: A Study Comparing the Bioavailability of a Taste-masked Delafloxacin Powder for Oral Suspension With the Delafloxacin Tablet in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Delafloxacin
Baxdela
BARDA
Bioavailability
Taste-masked
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2024-09-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Exposure (Area Under the Mean Concentration Time Curve [AUC]) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet
timeFrame: Day 1 (Pre-dose, up to 48 hours post-dose)
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of Delafloxacin Powder
timeFrame: Day 1 (Pre-dose, up to 48 hours post-dose)
measure: Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder
timeFrame: Day 1 (Pre-dose, up to 48 hours post-dose)
measure: Overall Exposure (AUC) of Delafloxacin Powder in the Fed State Compared to the Fasted State
timeFrame: Day 1 (Pre-dose, up to 48 hours post-dose)
measure: Number of Participants Experiencing Treatment-emergent Adverse Events After Receiving Delafloxacin Powder
timeFrame: Day 1 through Day 6
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
affiliation: Melinta Therapeutics, Inc.
name: Medical Information
role: STUDY_DIRECTOR
References: