Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Gonorrhoea Clinical Trial

Official title: Phase 1 Open Label Trial of the Safety, Tolerability, and Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is an open-label Phase I study of plasma, genitourinary, rectal, and pharyngeal pharmacokinetics of a single 1000mg oral dose of solithromycin. A total of 28 subjects (14 male, 14 female) will be enrolled and will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally. The study duration is approximately 18 months. 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. The secondary objective is to determine the safety and tolerability of a single 1000 mg oral dose of solithromycin in healthy adult subjects. ;

Related Conditions & MeSH terms

• Gonorrhea
• Gonorrhoea

• NCT number: NCT02348424
• Study type: Interventional
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2015
• Completion date: January 13, 2017