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CompletedNCT01966055Updated Feb 23, 2017

Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

A Phase 1 interventional study of Solithromycin in Bacterial Infections, sponsored by Melinta Therapeutics, Inc.. Completed at 11 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-02-23.

Sponsored by Melinta Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
01

Study summary

A study of the safety and pharmacokinetics of solithromycin capsules in adolescents

02

Conditions studied

  • Bacterial Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 13 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Melinta Therapeutics, Inc. is the lead sponsor of 30 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 12 to 17 yo male or female with suspected or confirmed bacterial infection

Exclusion criteria

Exclusion Criteria:

  • Bacterial meningitis
  • Clinical significant concomitant medical condition
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Solithromycin

    Drug: Solithromycin

Interventions

  • DrugSolithromycin
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What researchers measure

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents

    Time frame: 5 days

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Study locations

11 sites
  • Little Rock, Arkansas 72202, United States
  • San Diego, California 92123, United States
  • Chicago, Illinois 60611, United States
  • Louisville, Kentucky 40202, United States
  • Ann Arbor, Michigan 48109, United States
  • Hackensack, New Jersey 07601, United States
  • New York, New York 10032, United States
  • Portland, Oregon 97239, United States
  • Hershey, Pennsylvania 17033, United States
  • Galveston, Texas 77555-0701, United States
  • Houston, Texas 77030, United States
08

References and documents

Publications

  • Beechinor RJ, Cohen-Wolkowiez M, Jasion T, Hornik CP, Lang JE, Hernandez R, Gonzalez D. A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication. Ther Drug Monit. 2019 Dec;41(6):761-765. doi: 10.1097/FTD.0000000000000670. PubMed 31318840 ↗
  • Gonzalez D, James LP, Al-Uzri A, Bosheva M, Adler-Shohet FC, Mendley SR, Bradley JS, Espinosa C, Tsonkova E, Moffett K, Marquez L, Simonsen KA, Stoilov S, Boakye-Agyeman F, Jasion T, Hornik CP, Hernandez R, Benjamin DK Jr, Cohen-Wolkowiez M. Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents. Antimicrob Agents Chemother. 2018 Jul 27;62(8):e00692-18. doi: 10.1128/AAC.00692-18. Print 2018 Aug. PubMed 29891609 ↗
  • Gonzalez D, Palazzi DL, Bhattacharya-Mithal L, Al-Uzri A, James LP, Bradley J, Neu N, Jasion T, Hornik CP, Smith PB, Benjamin DK Jr, Keedy K, Fernandes P, Cohen-Wolkowiez M. Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2572-6. doi: 10.1128/AAC.02561-15. Print 2016 Apr. PubMed 26883693 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01966055
Lead sponsor
Melinta Therapeutics, Inc.
Collaborators
Department of Health and Human Services
Responsible party
Sponsor
First posted
Oct 21, 2013
Start date
Dec 2013
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Feb 23, 2017

Study contacts

Michael Cohen-Wolkowiez, MD
principal investigator · Duke Clinical Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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