Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents.

• Conditions: suspected or confirmed bacterial infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004037-10-Outside-EU/EEA
• Lead Sponsor: Cempra Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-10
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1.male or female 12 to 17 years of age (inclusive)
2. Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active
Are the trial subjects under 18? yes
Number of subjects for this age range: 16
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Diagnosis of bacterial meningitis or complicated intra-abdominal infection
2. Serum creatinine >2 mg/dL
3. Mean screening ECG QTcF >450 msec
4. ALT or AST >3x ULN
5. Direct bilirubin >ULN
6. Known tuberculosis, HIV, hepatitis B/C infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified