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Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01966055
Enrollment
13
Registered
2013-10-21
Start date
2013-12-31
Completion date
2014-09-30
Last updated
2017-02-23

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

Conditions

Bacterial Infections

Brief summary

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

Interventions

DRUGSolithromycin

Sponsors

Department of Health and Human Services
CollaboratorFED
Melinta Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Bacterial meningitis * Clinical significant concomitant medical condition

Design outcomes

Primary

MeasureTime frame
Area under the plasma concentration versus time curve (AUC) of solithromycin in adolescents5 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026