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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2024-09-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regimen A then B: Delafloxacin Tablet then Powder

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

Group Type EXPERIMENTAL

Delafloxacin

Intervention Type DRUG

Delafloxacin tablet

Delafloxacin Powder

Intervention Type DRUG

Delafloxacin powder for oral suspension formulation

Regimen B then A: Delafloxacin Powder then Tablet

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

Group Type EXPERIMENTAL

Delafloxacin

Intervention Type DRUG

Delafloxacin tablet

Delafloxacin Powder

Intervention Type DRUG

Delafloxacin powder for oral suspension formulation

Regimen C: Delafloxacin Powder

Participants will receive delafloxacin powder in fasted or fed states.

Group Type EXPERIMENTAL

Delafloxacin Powder

Intervention Type DRUG

Delafloxacin powder for oral suspension formulation

Regimen D (Optional): Delafloxacin Powder

Participants will receive delafloxacin powder in fasted or fed states.

Group Type EXPERIMENTAL

Delafloxacin Powder

Intervention Type DRUG

Delafloxacin powder for oral suspension formulation

Interventions

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Delafloxacin

Delafloxacin tablet

Intervention Type DRUG

Delafloxacin Powder

Delafloxacin powder for oral suspension formulation

Intervention Type DRUG

Other Intervention Names

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Baxdela Quofeni Delabaxi RX-3341 ABT-492 ABT-319492 WQ-3034

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes