NCT03718806

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

Completed Phase 1 Last updated 6 December 2018

What this trial tests

Phase 1 trial testing Zoliflodacin in Gonorrhea in 48 participants. Completed in 12 November 2018.

Timeline

3 October 2018

Primary endpoint
12 November 2018

12 November 2018

Quick facts

Lead sponsor	Drugs for Neglected Diseases
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	3 October 2018
Primary completion	12 November 2018
Estimated completion	12 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Zoliflodacin — full drug profile →
• high calorie, high fat breakfast

Conditions studied

• Gonorrhea — all drugs for Gonorrhea →

Sponsor

Drugs for Neglected Diseases — full company profile →

Who can join

Adults 18 to 55, any sex, with Gonorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of food on the pharmacokinetics of zoliflodacin granules for oral suspension: Phase I open-label randomized cross-over study in healthy subjects.
   Luckey A, Alirol E, Delhomme S, O'Donnell J, et al · · 2023 · cited 8× · PMID 36824016 · DOI 10.1111/cts.13487
2. Thorough QT Study To Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults.
   Newman LM, Kankam M, Nakamura A, Conrad T, et al · · 2021 · cited 7× · PMID 34606332 · DOI 10.1128/aac.01292-21