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OpenTrials
Terminated

NCT Number: NCT06612255

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

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.

Why the study stopped: Study goals not met
Terminated

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delafloxacin

Drug

Delafloxacin tablet

Other names: Baxdela, Quofeni, Delabaxi, RX-3341, ABT-492, ABT-319492, WQ-3034

Delafloxacin Powder

Drug

Delafloxacin powder for oral suspension formulation

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Maximum Observed Concentration (Cmax) of Delafloxacin Powder

    Time frame: 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).

  2. Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of Delafloxacin Powder

    Time frame: 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.

  3. Number of Participants Experiencing Treatment-emergent Adverse Events

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Collaborators

  • Biomedical Advanced Research and Development Authority

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2024
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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