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NCT02348424 · ClinicalTrials.gov registry record · Phase 1

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

A Phase 1 study of Gonorrhoea, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT02348424 is a Phase 1 study of Gonorrhoea that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 28 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT02348424, a Phase 1 study of Gonorrhoea, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
28 participants
Enrollment target
1
Study location

Study Summary

This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyngeal fluid samples after a single 1000mg oral dose.

Conditions Studied

Interventions

  • DRUG Solithromycin

Study Locations (1)

Maryland

  • Johns Hopkins Bayview Medical Center - Infectious Diseases - Baltimore

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2015-05-05
Est. Completion 2017-01-13
Phase Phase 1

What the Registry Record Tells You About NCT02348424

The ClinicalTrials.gov registry entry for NCT02348424 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Gonorrhoea appearing as the primary indexed condition, and to 1 intervention - of which Solithromycin is the first listed.

NCT02348424 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02348424 about?

NCT02348424 is a clinical study titled "Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin". This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. Study Objectives: The primary objective is to determine the pharmacokinetics of solithromycin in plasma, vaginal, cervical, seminal, rectal, and pharyn...

What is the current status of trial NCT02348424?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2015-05-05. Estimated completion is 2017-01-13.

What conditions does trial NCT02348424 study?

This clinical trial studies the following conditions: Gonorrhoea.

What interventions are being tested in trial NCT02348424?

The interventions under investigation include: Solithromycin (DRUG).

Who is sponsoring clinical trial NCT02348424?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02348424 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.