Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Intervention: AZD0914; Ceftriaxone
Intervention description: AZD0914 is an antimicrobial amorphous nonsterile powder. Group 1 receive 2000 mg; Group 2 receive 3000 mg. The drug name is also known as ETX0914.; Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears. A white to yellowish orange crystalline powder. Group 3 receives 500 mg reconstituted with 1 ml Lidocaine HCL 1%, intramuscularly.
Intervention MeSH terms: Ceftriaxone; Zoliflodacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: antibiotic; antimicrobial; AZD0914; Ceftriaxone; drug-resistant; sexually transmitted infection; urogenital gonorrhoea

Summary:

      This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male
      and female subjects, between the ages of 18 and 55, who are in good health and meet all
      eligibility criteria. The study is designed to assess the safety and efficacy of an
      antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to
      adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.
      Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of
      AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is
      also known as ETX0914.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Untreated subjects with signs and symptoms of urethral or cervical gonorrhea, or
        confirmed urethral or cervical gonorrhea* or any type of sexual contact in the past 14 days
        with an infected individual. *As defined by positive culture, NAAT test, or Gram-stain 2.
        Subject is able to give voluntary written informed consent before any study related
        procedure is performed 3. Willingness to comply with all protocol requirements 4. Male or
        non-pregnant female 18 to 55 years of age, inclusive 5. If the subject is female, a
        negative urine pregnancy test at Visit 1 prior to receiving study drug 6. Subject willing
        to abstain from anal, oral, and vaginal sexual intercourse or use condoms for 7 days
        following study drug dosing to prevent potential gonococcal reinfection 7. Male subjects
        must be surgically sterilized or use condoms for 7 days following study drug dosing 8.
        Female subject must be of non-childbearing potential* or if of childbearing potential, she
        must be using a highly effective method of birth control** *Non-childbearing potential is
        defined as being post-menopausal for at least two years, status after bilateral
        oophorectomy or status after hysterectomy. **Female subjects must avoid becoming pregnant
        by using one of the following acceptable methods of birth control for 30 days prior to
        study drug dosing: --Intrauterine contraceptive device; OR --Oral contraceptives; OR
        --Implanon®,Nexplanon®, DepoProvera®, contraceptive skin patch or NuvaRing®, OR --Tubal
        ligation OR --Abstinence AND --for 30 days following dosing, any method above should be
        used plus the required use of a barrier method (condom) by the male partner (even if
        vasectomized)

        Exclusion Criteria:

        1. Confirmed or suspected, complicated or systemic gonorrhea such as pelvic inflammatory
        disease, testicular pain, epididymitis, arthritis, conjunctivitis or endocarditis or
        clinical proctitis. 2. Known concomitant infection which would require immediate additional
        systemic antibiotics 3. Female subject currently breastfeeding 4. Use of any systemic or
        intravaginal antibiotics with activity against N. gonorrhoeae or systemic antivirals within
        30 days prior to study drug administration (topical and intravaginal antifugals are
        permitted). 5. Use of systemic corticosteroid drugs or other immunosuppressive therapy
        within 30 days prior to enrollment 6. Cytotoxic chemotherapy or radiation therapy within
        the previous 3 months 7. Known chronic renal, hepatic (including chronic hepatitis B or
        hepatitis C infection) or hematologic impairment, or other condition that could interfere
        with the absorption or metabolism of study drug 8. Any concomitant condition that, in the
        opinion of the Investigator, would preclude an evaluation of a response or make it unlikely
        that the course of therapy and follow-up could be completed 9. Subject HIV-infected and
        taking antiretroviral medication -- Subject not HIV-infected and taking antiretroviral for
        pre- or post- exposure prophylaxis -- Subject newly diagnosed with HIV infection or known
        to be HIV infected with evidence of immunosuppression, such as documented or patient
        reported CD4 count of < 200 10. Known allergy to cephalosporin or penicillin antibiotics
        11. Receipt or planned receipt of an investigational product in a clinical trial within 30
        days prior to or 7 days after study dose administration 12. Female subject is not willing
        to defer treatment for bacterial vaginosis until Visit 2 if she tests positive for
        bacterial vaginosis at Visit 1. 13. Use of drugs that act as inducer/inhibitors of CYP3A4/5
        or the P-gp efflux transporter* within 30 days prior to study drug administration *such as
        itraconozale, fluconazole, ketoconazole, verapamil, diltiazem, amiodarone, felodipine,
        carbamazepine, phenytoin, or St. John's wort 14. Subjects known to be co-infected with
        chlamydia prior to study entry 15. Subjects with medically documented cardiac arrhythmia
        16. Known allergy to lidocaine (or local anesthetics of the amide type, e.g., articaine,
        bupivacaine, mepivacaine, prilocaine, ropivacaine) or the antimicrobial preservative
        methylparaben.