Completed PHASE1 INTERVENTIONAL 4-arm 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

Sponsor: Drugs for Neglected Diseases

Conditions Gonorrhea

Interventions Zoliflodacin high calorie, high fat breakfast

Updated 5 times since 2018 Last updated: Dec 5, 2018 Started: Oct 3, 2018 Primary completion: Nov 12, 2018 Completion: Nov 12, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Gonorrhea and is currently completed. Drugs for Neglected Diseases leads this study, which shows 5 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jan 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Nov 2018 — Jan 2019 [monthly]

Recruiting PHASE1

First recorded

Oct 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Drugs for Neglected Diseases
Quotient Sciences

Data source: Drugs for Neglected Diseases

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Miami, United States