Uncomplicated urogenital gonorrhea MedDRA version: 19.0 Level: LLT Classification code 10018611 Term: Gonorrhea, postpartum System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10066614 Term: Gonorrhea recurrent System Organ Class: 100000004862 MedDRA version: 19.0 Level:
Conditions
Interventions
Product Name: GSK2140944 Capsules, 500 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Gepotidacin
CAS Number: 1624306-20-2
C
Sponsors
GlaxoSmithKline Research and Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 40 mIU/mL and estradiol =65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: 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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the effectiveness of single oral doses of GSK2140944 to treat adult subjects with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae;Secondary Objective: To evaluate the safety and tolerability of single oral doses of GSK2140944 in subjects with gonorrhea;Primary end point(s): Culture-confirmed bacterial eradication of urogenital N. gonorrhoeae at the Test-of-Cure Visit;Timepoint(s) of evaluation of this end point: Day 4 to 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events (AEs), vital sign assessments, laboratory values, physical examinations, electrocardiograms (ECGs);Timepoint(s) of evaluation of this end point: Day 1 and Day 4 to 8 | — |
Countries
United Kingdom, United States
Contacts
Public ContactProject Management
PPD
Outcome results
None listed