Status:
COMPLETED
A Dose-Ranging Study Evaluating the Efficacy, Safety, and Tolerability of GSK2140944 in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
Lead Sponsor:
GlaxoSmithKline
Conditions:
Gonorrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-lab...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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
- 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.
Key Trial Info
Start Date :
April 15 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02294682
Start Date
April 15 2015
End Date
July 27 2016
Last Update
May 23 2017
Active Locations (14)
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1
GSK Investigational Site
Fountain Valley, California, United States, 92708
2
GSK Investigational Site
Los Angeles, California, United States, 90028
3
GSK Investigational Site
Los Angeles, California, United States, 90069
4
GSK Investigational Site
Palm Springs, California, United States, 92262