This is a phase I, parallel, open-label, randomized, cross-over, single-center study with zoliflodacin administered as granules for oral suspension with or without food. It is planned to enroll 2 cohorts (Cohorts 1 and 2) of 24 subjects each (48 subjects in total), with the target of achieving data in 20 evaluable subjects per cohort. Single doses of zoliflodacin will be assessed within each cohort in a two period cross-over design. Each subject will receive one of the following regimens per period, depending on cohort, in a sequence according to the randomization schedule (per cohort, subjects will be randomized immediately before dosing in Period 1), separated by a minimum 4 day washout between each period. The actual length of washout period may change pending emerging PK data. Cohort 1: * Regimen A: 3 g zoliflodacin oral suspension; oral administration after an overnight fast * Regimen B: 3 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast Cohort 2 * Regimen C: 4 g zoliflodacin oral suspension; oral administration after an overnight fast * Regimen D: 4 g zoliflodacin oral suspension; oral administration with a standardized high calorie, high-fat breakfast
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
oral suspension; oral administration
fasted/fed conditions
Quotient Sciences
Miami, Florida, United States
PK parameter of zoliflodacin : Cmax
the maximum observed concentration of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Time frame: Day 3
PK parameter of zoliflodacin : Tmax
Tmax (the elapsed time from dosing at which Cmax was apparent) of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Time frame: Day 3
PK parameter of zoliflodacin : AUC
Area Under the Curve of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Time frame: Day 3
PK parameter of zoliflodacin : T1/2
the apparent elimination half-life of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Time frame: Day 3
safety and tolerability of zoliflodacin
safety and tolerability of zoliflodacin after a single oral 3 g dose and a single oral 4 g dose administered as granules for oral suspension in healthy male and female subjects
Time frame: end of study
relative bioavailability (Cmax) of zoliflodacin in the fed and fasted states
To determine the maximum observed concentration (Cmax) of zoliflodacin in the fed and fasted states
Time frame: Day 3
relative bioavailability (AUC) of zoliflodacin in the fed and fasted states
To determine the Area Under the Curve (AUC) of zoliflodacin in the fed and fasted states
Time frame: Day 3
zoliflodacin effect on QT intervals
To collect 12-lead Holter recordings to assess QTcP, QTcF, QT intervals corrected with Bazett's formula
Time frame: Day 2
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