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



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:March 2016
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

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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 Gonorrhea Caused by Neisseria Gonorrhoeae

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.


Inclusion Criteria:

- The subject is an adult male or female at least 18 years of age at the time of
signing informed consent who meets one of the following criteria:

1. A non-pregnant, non-lactating female of childbearing potential who 1) is
sexually inactive by abstinence, 2) has a sole male partner who has been
sterilized, or 3) uses a contraceptive method with a failure rate of <1% through
the Test-of-Cure Visit. Females of childbearing potential must not become
pregnant during the study.

2. A female of non-childbearing potential, which includes the following: Females
who are surgically sterile with a documented hysterectomy and/or bilateral
oophorectomy; Females with documented tubal ligation. If the procedure was done
hysteroscopically, the effectiveness of tubal occlusion must have been
documented by hysterosalpingogram after the procedure (typically 3 months after
the procedure); Females who are post-menopausal, defined as amenorrhoeic for
greater than 1 year. For women whose menopausal status is in doubt, documented
previous confirmatory blood samples with follicle-stimulating hormone >40 milli
international units (mIU)/millilitre (mL) and estradiol <40 picograms (pg)/mL
(<140 picomoles [pmol]/litre [L]) will need to be confirmed, or they will be
required to use one of the acceptable contraception methods. Note: For the
purposes of these criteria, "documented" includes information obtained via a
verbal interview with the subject or from the subject's medical records.

- There is clinical suspicion that the subject has a urogenital gonococcal infection
(e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain
presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a
partner diagnosed with gonorrhea within the past 14 days, as reported by the
subject). Note: All subjects will be tested for N. gonorrhoeae, but these results
will not be used to determine subject eligibility for enrollment in the study.

- The subject has provided written, dated, informed consent and is willing and able to
comply with the study protocol.

Exclusion Criteria:

- The subject is pregnant or nursing.

- The subject is a hysterectomized female without a cervix.

- The subject is a male with a current diagnosis of epididymitis or orchitis at the
time of the Baseline Visit.

- The subject has a body mass index >=40.0 kilograms (kg)/square meter (m^2).

- The subject has a serious underlying disease that could be imminently life
threatening, or the subject is unlikely to survive for the duration of the study
period.

- The subject has a medical condition or requires medication that may be aggravated by
inhibition of acetylcholinesterase, such as: Poorly controlled asthma or chronic
obstructive pulmonary disease at baseline and, in the opinion of the investigator, is
not stable on current therapy; Acute severe pain, uncontrolled with conventional
medical management; Active peptic ulcer disease; Parkinson's disease; Myasthenia
gravis; A history of seizure disorder requiring medications for control. This does
not include a history of childhood febrile seizures; Any evidence of mechanical
obstruction of the urinary or digestive tracks.

- The subject has had any past history or current diagnosis of Clostridium difficile
infection at the time of the Baseline Visit.

- The subject, in the judgment of the investigator, would not be able or willing to
comply with the protocol or complete study follow-up.

- The subject has a history of sensitivity to the study medication, or components
thereof, or a history of a drug or other allergy that, in the opinion of the
investigator or medical monitor, contraindicates their participation.

- The subject has a PR interval <120 or >220 milliseconds (msec). Note: Subjects
without an evaluable PR interval (e.g., stable atrial fibrillation) are not eligible
for this study.

- The subject has a corrected QT (QTc) >450 msec or a QTc >480 msec for subjects with
bundle branch block. Note: The QTc is the QT interval corrected for heart rate
according to either Bazett formula (QTcB), Fridericia formula (QTcF), machine, or
manual overread.

- The subject has QRS duration <70 or >120 msec.

- The subject has pre-existing Grade II atrioventricular block or higher or a history
of significant vasovagal and/or syncopal episodes or episodes of symptomatic
bradycardia.

- The subject has a current or chronic history of liver disease (with the exception of
Gilbert's syndrome), including symptomatic viral hepatitis and moderate to severe
liver insufficiency (Child Pugh class B or C).

- The subject has been previously enrolled in this study or has previously been treated
with GSK2140944.

- The subject has participated in a clinical trial and has received an investigational
product within 30 days or 5 half-lives, whichever is longer.

- The subject has the following gonococcal infections: Suspected or confirmed pelvic
inflammatory disease; Suspected or confirmed gonococcal arthritis; Other evidence of
disseminated gonococcal infection.

- The subject has received treatment with a systemic or intravaginal antibacterial
within 14 days of study entry.

- Subject is taking a medication that has a known risk of torsades de pointes.
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Omaha, Nebraska 68131
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Atlanta, Georgia 30341
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Jenkintown, Pennsylvania 19046
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Los Angeles, California 90025
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Los Angeles, California 90025
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San Juan, 00927
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