Gonorrhea Clinical Trial
Official title:
A Phase 1, Open-Label, Study to Investigate Pharmacokinetics, Effect of Food and Safety of a New Immediate-Release Formulation of Zoliflodacin in Healthy Subjects
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
n/a
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