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

NCT06612255 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: ML-DEL-101-3727-11009679QSC300553
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Delafloxacin; Baxdela; BARDA; Bioavailability; Taste-masked

Outcome Measures

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

  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 Outcomes (3)

• Maximum Observed Concentration (Cmax) of Delafloxacin Powder

  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

  Pre-dose on Day 1, up to 48 hours post-dose

• Number of Participants Experiencing Treatment-emergent Adverse Events

  Day 1 through Day 6

Study Arms (4)

Regimen A then B: Delafloxacin Tablet then Powder

EXPERIMENTAL

Participants will receive delafloxacin tablet in the fasted state (Regimen A), followed by delafloxacin powder in the fasted state (Regimen B).

Drug: Delafloxacin; Drug: Delafloxacin Powder

Regimen B then A: Delafloxacin Powder then Tablet

EXPERIMENTAL

Participants will receive delafloxacin powder in the fasted state (Regimen B), followed by delafloxacin tablet in the fasted state (Regimen A).

Drug: Delafloxacin; Drug: Delafloxacin Powder

Regimen C: Delafloxacin Powder

EXPERIMENTAL

Participants will receive delafloxacin powder in fasted or fed states.

Drug: Delafloxacin Powder

Regimen D (Optional): Delafloxacin Powder

EXPERIMENTAL

Participants will receive delafloxacin powder in fasted or fed states.

Drug: Delafloxacin Powder

Interventions

Delafloxacin DRUG

Delafloxacin tablet

Also known as: Baxdela, Quofeni, Delabaxi, RX-3341, ABT-492, ABT-319492, WQ-3034

Regimen A then B: Delafloxacin Tablet then Powder; Regimen B then A: Delafloxacin Powder then Tablet

Delafloxacin Powder DRUG

Delafloxacin powder for oral suspension formulation

Regimen A then B: Delafloxacin Tablet then Powder; Regimen B then A: Delafloxacin Powder then Tablet; Regimen C: Delafloxacin Powder; Regimen D (Optional): Delafloxacin Powder

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Melinta Therapeutics, Inc.: lead
• Biomedical Advanced Research and Development Authority: collaborator

Study Sites (1)

Quotient Sciences

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

delafloxacin; WQ 3034

Limitations and Caveats

Following interim review of the pharmacokinetics and safety data, the decision was made to terminate the study early owing to lower-than-expected exposure levels for delafloxacin powder for oral suspension.

Results Point of Contact

• Title: Medical Information
• Organization: Melinta Therapeutics, LLC

medinfo@melinta.com

1-844-633-6568

Study Officials

• Medical Information

  Melinta Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: June 3, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: September 26, 2025
• Results First Posted: September 26, 2025

Record last verified: 2025-09

Locations

GB (1)