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Pharmacokinetics and Safety of Solithromycin Capsules in paediatric subjects.

A Phase I, open-label, multi-centre study to evaluate the PK and safety of solithromycin as add-on therapy to antimicrobial agent administered to paediatric subjects with a suspected or confirmed bacterial infection.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004041-26-Outside-EU/EEA
Enrollment
64
Registered
2014-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2014-10-27

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

Conditions

suspected or confirm bacterial infection

Interventions

Product Name: solithromycin Product Code: CEM-101 Pharmaceutical Form: Capsule INN or Proposed INN: solithromycin Other descriptive name: SOLITHROMYCIN Concentration unit: mg milligram(s) Concentratio

Sponsors

Cempra Pharmaceuticals , Inc
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Serum creatinine >2 mg/dL 2. Hepatic dysfunction – ALT or AST >3x ULN or direct bilirubin >ULN

Design outcomes

Primary

MeasureTime frame
Main Objective: Determine the PK profile of solithromycin (IV and oral);Secondary Objective: Determine the safety and tolerability Solithromycin concentration in dried blood spots;Primary end point(s): PK samples on Day 1 and Days 3 to 5;Timepoint(s) of evaluation of this end point: Day 1: prior to dosing, 0.5-1.5h (if oral) or at the end of infusion (if IV), 2-4h, 8-10h, and 23-24h after the first dose. Day 3: prior to dosing Day 4 or 5:prior to dosing, 0.5-1.5h (if oral) or at the end of infusion (if IV), 2-4h, 8-10h, 16-18h, and 23-24h after the first dose.—

Secondary

MeasureTime frame
Secondary end point(s): Safety and tolerability Solithromycin concentration in dried blood spots;Timepoint(s) of evaluation of this end point: baseline and end of study—

Countries

United States

Contacts

Public ContactClinical Trials Info

Cempra Pharmaceuticals, Inc

clinicaltrials@cempra.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026