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    Summary
    EudraCT Number:2015-005120-26
    Sponsor's Protocol Code Number:BTZ116576
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-005120-26
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of GSK2140944 in the Treatment of Gonorrhea in Adults
    A.4.1Sponsor's protocol code numberBTZ116576
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDepartment of Health and Human Services (HHS)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address3900 Paramount Parkway
    B.5.3.2Town/ cityMorrisville
    B.5.3.3Post codeNC 27560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+9105582051
    B.5.5Fax number+9193795989
    B.5.6E-mailvincent.lopez@ppdi.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGSK2140944 Capsules, 500 mg
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGepotidacin
    D.3.9.1CAS number 1624306-20-2
    D.3.9.2Current sponsor codeGSK2140944
    D.3.9.4EV Substance CodeSUB73015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Uncomplicated urogenital gonorrhea
    E.1.1.1Medical condition in easily understood language
    Gonorrhoea is an infection of genital area
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10018611
    E.1.2Term Gonorrhea, postpartum
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066614
    E.1.2Term Gonorrhea recurrent
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10018610
    E.1.2Term Gonorrhea, antepartum
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10070744
    E.1.2Term Oral gonorrhea
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10062843
    E.1.2Term Gonorrhea of anus
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10062844
    E.1.2Term Gonorrheal discharge
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10018604
    E.1.2Term Gonorrhea
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10062842
    E.1.2Term Gonorrhea carrier
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10062845
    E.1.2Term Gonorrheal salpingitis
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the effectiveness of single oral doses of GSK2140944 to treat adult subjects with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of single oral doses of GSK2140944 in subjects with gonorrhea
    E.2.3Trial contains a sub-study No
    E.3Principal 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 <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.
    E.4Principal 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 <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 enrolled in this study or has previously been treated with GSK2140944.
    16. The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.

    Gonococcal Infections

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

    Prior Antibiotic Use

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

    Prohibited Baseline Medications

    19. Subject is taking a medication that has a known risk of torsades de pointes (TdP) per the Crediblemeds.org "Known Risk of TdP" category at the time of their Baseline (Day 1) Visit (Section 6.10.2) or consumed grapefruit or other juice containing flavonoids (e.g., cranberry juice) within 24 hours before study drug administration (Section 6.9.2).
    E.5 End points
    E.5.1Primary end point(s)
    Culture-confirmed bacterial eradication of urogenital N. gonorrhoeae at the Test-of-Cure Visit
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 4 to 8
    E.5.2Secondary end point(s)
    Adverse events (AEs), vital sign assessments, laboratory values, physical examinations, electrocardiograms (ECGs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 and Day 4 to 8
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last patient last visit (LVLS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects testing positive for C.trachomatis at the Baseline Visit should be treated with a single 1-g dose of azithromycin or local SOC at the Test-of-Cure Visit.Treatment for C.trachomatis should be administered after all study procedures have been completed.Subjects with culture-confirmed bacterial persistence of urogenital and, as appropriate, rectal and/or pharyngeal N.gonorrhoeae at the Test-of-Cure Visit should receive appropriate alternative therapy at the investigator’s discretion.

    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-27
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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