Clinical Trial: A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Randomized, Multicenter, Dose-Ranging Study in Adult Subjects Evaluating the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Uncomplicated Urogenital <

Brief Summary: GSK2140944 has demonstrated in vitro activity against Neisseria (N.) gonorrhoeae, including ciprofloxacin resistant and susceptible strains. This study is a Phase II, randomized, multicenter, open-label, dose ranging study designed to inform the optimal oral dose of GSK2140944 by further characterizing the efficacy, safety, and tolerability in subjects with uncomplicated urogenital gonorrhea due to N. gonorrhoeae. Subjects will be randomly assigned to receive either a single 1500 milligrams (mg) or 3000 mg oral dose of GSK2140944. Appropriate safety and microbiological assessments will be conducted at the Baseline (Day 1) Visit and repeated at the Test-of-Cure (Day 4 to 8) Visit. The study duration will be approximately 1 week. Approximately 60 microbiologically evaluable subjects (30 subjects in each treatment arm) will complete the study if both arms remain active throughout the study.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Culture-confirmed bacterial eradication of urogenital N. gonorrhoeae at the Test-of-Cure Visit [ Time Frame: Baseline and Test-of-Cure Visit (Day 4 to 8) ]

Pre-treatment urogenital, pharyngeal, and rectal swab specimens will be obtained for bacteriological culture for N. gonorrhoeae at the Baseline Visit. "Test of Cure" will be defined by infection site (i.e., urogenital and, as appropriate, rectal and/or pharyngeal) as culture confirmed bacterial eradication of N. gonorrhoeae observed 3 to 7 days post-treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of subjects with adverse events (AEs) [ Time Frame: Day 1 to Day 8 ]
    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Vital sign assessments [ Time Frame: Day 1 to Day 8 ]
    Vital sign assessments will include temperature, systolic and diastolic blood pressure, pulse rate and respiratory rate.
  • Clinical laboratory assessments [ Time Frame: Day 1 to Day 8 ]
    Clinical laboratory assessments will include hematology, clinical chemistry and urinalysis parameters.
  • Physical examinations [ Time Frame: Day 1 to Day 8 ]
    Physical examinations will include assessments of the respiratory, cardiovascular, abdomen, gastrointestinal, urogenital systems, as well as pharyngeal and rectal examinations.
  • Electrocardiogram (ECG) assessments [ Time Frame: Day 1 to Day 8 ]
    A single 12-lead ECG will be obtained at each time point during the study, using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: November 17, 2014
Date Started: April 2015
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017