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

Melinta Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Delafloxacin; Drug: Delafloxacin Powder

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT06612255

QSC300553 (Other Identifier)

1009679 (Other Identifier)

ML-DEL-101-3727-1

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

Regimen A then B: Delafloxacin Tablet then Powder

Experimental group

Description:

Participants will receive delafloxacin tablet in the fasted state, followed by delafloxacin powder in the fasted state.

Treatment:

Drug: Delafloxacin Powder

Drug: Delafloxacin

Regimen B then A: Delafloxacin Powder then Tablet

Experimental group

Description:

Participants will receive delafloxacin powder in the fasted state, followed by delafloxacin tablet in the fasted state.

Treatment:

Drug: Delafloxacin Powder

Drug: Delafloxacin

Regimen C: Delafloxacin Powder

Experimental group

Description:

Participants will receive delafloxacin powder in fasted or fed states.

Treatment:

Drug: Delafloxacin Powder

Regimen D (Optional): Delafloxacin Powder

Experimental group

Description:

Participants will receive delafloxacin powder in fasted or fed states.

Treatment:

Drug: Delafloxacin Powder