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

NCT03718806 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-12-06

No results posted yet for this study

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

DRUG

Zoliflodacin

oral suspension; oral administration

OTHER

high calorie, high fat breakfast

fasted/fed conditions

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Juan Perez-Morales, MD · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2018-11-12
Completion
2018-11-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03718806 on ClinicalTrials.gov