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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Delafloxacin; Drug: Delafloxacin Powder

• Registration Number: NCT06612255
• Lead Sponsor: Melinta Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-03
• Primary Completion: 2024-09-11
• Study Completion: 2024-09-11
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Study First Posted: 2024-09-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Regimen A then B: Delafloxacin Tablet then Powder	Delafloxacin Powder	Participants will receive delafloxacin tablet in the fasted state, followed by delafloxacin powder in the fasted state.
Regimen B then A: Delafloxacin Powder then Tablet	Delafloxacin Powder	Participants will receive delafloxacin powder in the fasted state, followed by delafloxacin tablet in the fasted state.
Regimen C: Delafloxacin Powder	Delafloxacin Powder	Participants will receive delafloxacin powder in fasted or fed states.
Regimen D (Optional): Delafloxacin Powder	Delafloxacin Powder	Participants will receive delafloxacin powder in fasted or fed states.
Regimen A then B: Delafloxacin Tablet then Powder	Delafloxacin	Participants will receive delafloxacin tablet in the fasted state, followed by delafloxacin powder in the fasted state.
Regimen B then A: Delafloxacin Powder then Tablet	Delafloxacin	Participants will receive delafloxacin powder in the fasted state, followed by delafloxacin tablet in the fasted state.

Primary Outcome Measures

Name	Time	Method
Overall Exposure (Area Under the Mean Concentration Time Curve [AUC]) of Delafloxacin Powder Compared to Oral Delafloxacin Tablet	Day 1 (Pre-dose, up to 48 hours post-dose)

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of Delafloxacin Powder	Day 1 (Pre-dose, 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	Day 1 (Pre-dose, up to 48 hours post-dose)
Overall Exposure (AUC) of Delafloxacin Powder in the Fed State Compared to the Fasted State	Day 1 (Pre-dose, up to 48 hours post-dose)
Number of Participants Experiencing Treatment-emergent Adverse Events After Receiving Delafloxacin Powder	Day 1 through Day 6

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Ruddington, Nottingham, United Kingdom