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Completed Phase 1 Interventional Accepts healthy volunteers

Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin

NCT02348424
Conditions
Gonorrhoea
Interventions
Solithromycin
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 45 Years
Enrollment
28 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
1
States / cities
Baltimore, Maryland
Conditions
Community-Acquired Bacterial Pneumonia
Interventions
Levofloxacin, CEM-101
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
132 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
45
States / cities
Birmingham, Alabama • Flagstaff, Arizona • Bell Gardens, California + 41 more
Conditions
Uncomplicated Urogenital Gonorrhea
Interventions
solithromycin, Solithromycin (CEM-101)
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
19 Years and older
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
2
States / cities
Birmingham, Alabama • Seattle, Washington
Conditions
Uncomplicated Urogenital Gonorrhea
Interventions
solithromycin, ceftriaxone, azithromycin
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
15 Years and older
Enrollment
264 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2017
U.S. locations
3
States / cities
Baltimore, Maryland • Cleveland, Ohio • Toledo, Ohio
Conditions
Bacterial Infections
Interventions
Solithromycin
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
12 Years to 17 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
11
States / cities
Little Rock, Arkansas • San Diego, California • Chicago, Illinois + 8 more
Conditions
Bacterial Infection
Interventions
solithromycin
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
Up to 17 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
31
States / cities
Little Rock, Arkansas • Orange, California • Palo Alto, California + 28 more
Conditions
Community-acquired Bacterial Pneumonia
Interventions
Solithromycin, Moxifloxacin
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
863 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
62
States / cities
Mobile, Alabama • Little Rock, Arkansas • Chino, California + 53 more
Conditions
Community-acquired Bacterial Pneumonia
Interventions
Solithromycin, Moxifloxacin, Placebo to match solithromycin
Drug · Other
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
18 Years and older
Enrollment
860 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
25
States / cities
Glendale, California • Los Angeles, California • Mission Hills, California + 18 more
Conditions
Nonalcoholic Steatohepatitis
Interventions
solithromycin
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
18 Years to 70 Years
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
1
States / cities
Cleveland, Ohio
Conditions
Community-acquired Bacterial Pneumonia
Interventions
Solithromycin, Standard of Care
Drug
Lead sponsor
Melinta Therapeutics, Inc.
Industry
Eligibility
2 Months to 17 Years
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
21
States / cities
Little Rock, Arkansas • Los Angeles, California • Sacramento, California + 18 more