A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Gonorrhea in Adults
- Conditions
- ncomplicated urogenital gonorrheaMedDRA version: 19.0 Level: LLT Classification code 10018611 Term: Gonorrhea, postpartum System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10066614 Term: Gonorrhea recurrent System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10018610 Term: Gonorrhea, antepartum System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10070744 Term: Oral gonorrhea System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10062843 Term: Gonorrhea of anus System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10062844 Term: Gonorrheal discharge System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10018604 Term: Gonorrhea System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10062842 Term: Gonorrhea carrier System Organ Class: 100000004862MedDRA version: 19.0 Level: LLT Classification code 10062845 Term: Gonorrheal salpingitis System Organ Class: 100000004862
- Registration Number
- EUCTR2015-005120-26-GB
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 106
1. 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. A nonpregnant, nonlactating 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.
b. A female of non-childbearing potential, which includes the following:
i. Females who are surgically sterile with a documented hysterectomy and/or bilateral oophorectomy.
ii. 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).
iii. Females who are postmenopausal, 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 mIU/mL and estradiol <40 pg/mL (<140 pmol/L) will need to be confirmed, or they will be required to use one of the contraception methods described.
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.
2. There is clinical suspicion that the subject has a urogenital gonococcal infection as confirmed by the presence of purulent discharge upon physical examination and by one or more of the following:
-A prior culture or nucleic acid amplification test (NAAT) positive for N. gonorrhoeae
-A Gram stain positive or presumptive for Gram-negative diplococci
-Subject-reported sexual contact with a partner diagnosed with gonorrhea within 14 days
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.
3. The subject has provided written, dated, informed consent and is willing and abl2e to comply with the study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
Medical History
1. The subject is pregnant or nursing.
2. The subject is a hysterectomized female without a cervix.
3. The subject is a male with a current diagnosis of epididymitis or orchitis at the time of the Baseline Visit.
4. The subject has a body mass index greater than or equal to 40.0 kg/m2.
5. 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.
6. 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
7. The subject has had any past history or current diagnosis of Clostridium difficile infection at the time of the Baseline Visit.
8. The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
9. 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.
Cardiac Exclusions
10. The subject has a PR interval <120 or >220 msec.
Note: Subjects without an evaluable PR interval (e.g., stable atrial fibrillation) are not eligible for this study.
11. 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.
12. The subject has QRS duration <70 or >120 msec.
13. The subject has the following cardiovascular medical conditions or family history:
-Pre-existing Grade II atrioventricular block or higher or a history of significant vasovagal and/or syncopal episodes or episodes of symptomatic bradycardia.
-Pre-existing or known moderate to severe heart failure
-Family history of QT prolongation or sudden death
Hepatic
14. 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).
Previous Trial Participation
15. The subject has been previously en
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method