Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02268279

Enrollment

Registered

2014-10-20

Start date

2015-01-31

Completion date

2016-10-31

Last updated

2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infection

Brief summary

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

Interventions

DRUGsolithromycin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

Healthy volunteers

Inclusion criteria

* Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.

Exclusion criteria

* Serum creatinine \>2 mg/dL * Positive pregnancy test in females of childbearing potential * History of intolerance or hypersensitivity to macrolide antibiotics

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents	5 to 7 days

Countries

Bulgaria, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026