Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea

• Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea [ Time Frame: One day after study drug dosing, and 3 to 9 days after study drug dosing ]
  Adverse event reporting, clinical laboratory evaluations
• The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline) [ Time Frame: 3 to 9 days after study drug dosing ]
• Eradication or persistence of N. gonorrhoeae nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ]
• Eradication or persistence of Chlamydia trachomatis nucleic acid (as measured by positive NAAT assay) from urethral and cervical specimens [ Time Frame: 3 to 9 days after study drug dosing ]
• In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated [ Time Frame: Baseline and (if applicable) 3 to 9 days after study drug dosing ]

• Drug: solithromycin
  A single oral dose of 1200 mg solithromycin (CEM-101)
• Drug: Solithromycin (CEM-101)
  A single oral dose of 1000 mg solithromycin

• Experimental: Solithromycin (CEM-101)
  A single oral dose of 1200 mg solithromycin
  Intervention: Drug: solithromycin
• Experimental: Solithromycin 1000 mg
  A single oral dose of 1000 mg solithromycin
  Intervention: Drug: Solithromycin (CEM-101)

Inclusion Criteria:

1. Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact)
2. Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion.
3. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment.

Exclusion Criteria:

1. Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis.
2. Known HIV, chronic hepatitis B, or hepatitis C infection.
3. Known concomitant infection which would require additional systemic antibiotics.
4. Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration.
5. Current use of corticosteroid drugs or other immunosuppressive therapy.
6. Cytotoxic chemotherapy or radiation therapy within the previous 3 months.
7. Known significant renal, hepatic, or hematologic impairment.
8. History of intolerance or hypersensitivity to macrolide antibiotics.
9. Any concomitant condition that, in the opinion of the Investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy and follow-up could be completed (e.g., life expectancy <30 days).