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

Study Overview
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Brief Summary
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To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.

Official Title
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An Open-Label Study to Evaluate the Efficacy and Safety of a Single-Dose of Oral CEM-101 in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea

Conditions
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Uncomplicated Urogenital Gonorrhea

Intervention / Treatment
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* Drug: solithromycin
* Drug: Solithromycin (CEM-101)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of a urogenital gonococcal infection (prior culture, NAAT test, Gram stain, sexual contact) Willing to abstain from anal, oral, or vaginal sexual intercourse or use condoms until study completion. Females of childbearing potential (including females less than 2 years post-menopausal) must have a negative pregnancy test at enrollment. Exclusion Criteria: Confirmed, or suspected, complicated or systemic gonococcal infections such as pelvic inflammatory disease, arthritis, or endocarditis. Known HIV, chronic hepatitis B, or hepatitis C infection. Known concomitant infection which would require additional systemic antibiotics. Use of systemic or intravaginal antibiotics within 30 days prior to study drug administration. Current use of corticosteroid drugs or other immunosuppressive therapy. Cytotoxic chemotherapy or radiation therapy within the previous 3 months. Known significant renal, hepatic, or hematologic impairment. History of intolerance or hypersensitivity to macrolide antibiotics. 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).

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solithromycin (CEM-101)<br>A single oral dose of 1200 mg solithromycin | Drug: solithromycin<br>* A single oral dose of 1200 mg solithromycin (CEM-101)<br>|
| Experimental: Solithromycin 1000 mg<br>A single oral dose of 1000 mg solithromycin | Drug: Solithromycin (CEM-101)<br>* A single oral dose of 1000 mg solithromycin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bacterial eradication rate, as measured by conversion from positive Neisseria gonorrhoeae baseline urethral or cervical culture to negative |  | 3 to 9 days after study drug dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of a single oral dose of CEM-101 in adult patients with uncomplicated urogenital gonorrhea | Adverse event reporting, clinical laboratory evaluations | One day after study drug dosing, and 3 to 9 days after study drug dosing | 
| The bacterial eradication of rectal or pharyngeal gonococcal infection (if positive culture at baseline) |  | 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 |  | 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 |  | 3 to 9 days after study drug dosing | 
| In vitro minimum inhibitory concentrations (MICs) of gonococcal strains isolated |  | Baseline and (if applicable) 3 to 9 days after study drug dosing |