NCT03718806

Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Gonorrhea

Interventions

Type	Name	Description
DRUG	Zoliflodacin	oral suspension; oral administration
OTHER	high calorie, high fat breakfast	fasted/fed conditions

Timeline

• Start date: 2018-10-03
• Primary completion: 2018-11-12
• Completion: 2018-11-12
• First posted: 2018-10-24
• Last updated: 2018-12-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study