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Clinical Trial Summary

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


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03718806
Study type Interventional
Source Drugs for Neglected Diseases
Contact
Status Completed
Phase Phase 1
Start date October 3, 2018
Completion date November 12, 2018

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