Trials / Completed
CompletedNCT01591447
Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Melinta Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
To determine the safety and efficacy of a single dose of solithromycin (CEM-101) for the treatment of uncomplicated urogenital gonorrhea.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | solithromycin | A single oral dose of 1200 mg solithromycin (CEM-101) |
| DRUG | Solithromycin (CEM-101) | A single oral dose of 1000 mg solithromycin |
Timeline
- Start date
- 2012-05-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2012-05-04
- Last updated
- 2017-03-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01591447. Inclusion in this directory is not an endorsement.