Pharmacokinetics (PK) and Safety Study of Solithromycin as Add-on Therapy in Adolescents and Children with Suspected or Confirmed Bacterial Infectio

Phase 1

• Conditions: Adolescents and Children with Suspected or Confirmed Bacterial Infection; MedDRA version: 19.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-003753-34-BG
• Lead Sponsor: Cempra Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-05
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. <18 years of age
2. Informed consent from parent(s) or other legally authorized representative(s) and informed
assent from patient (if age appropriate according to local requirements)
3. Suspected or confirmed bacterial infection with organisms against which solithromycin is
expected to be active as described in the protocol.
4. Likely to survive the current illness
5. Postmenstrual age (gestational age + postnatal age in weeks) =37 weeks
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
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.Evidence or history of clinically significant medical condition that may, in the assessment of the investigator, impair study participation or pose a significant safety risk or diminish the patient’s ability to undergo all study procedures and assessments
2.Received an investigational drug, therapy, and/or device within 30 days of the first dose of the study drug
3.Consumed Seville oranges or products containing Seville orange components,; or consumed grapefruit, grapefruit juice, or juices containing grapefruit; or consumed pomegranates, pomegranate juice, or juices containing pomegranates within 7 days prior to the first dose of study drug
4.Received any herbal supplements (unless pre-approved by the medical monitor and documented) in the 7 days prior to the first dose of study drug.
5.Prior dosing in this protocol
6.Serum creatinine >2 mg/dL
7.Hepatic dysfunction evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase >3 times(AST) >3x upper normal limit (ULN) or direct bilirubin greater than ULN
8.Treatment with the following drugs within 72 hours prior to first dose of study drug or expected to receive these drugs during the treatment phase: clarithromycin or erythromycin; drugs that potently inhibit CYP3A4 (nefazodone, fluconazole, ketoconazole, fluvoxamine, conivaptan, diltiazem, verapamil, aprepitant, ticlopidine, crizotimib, and imatinib); CYP3A4 inducers (rifampin, phenytoin, carbamazepine, phenobarbital, troglitazone, pioglitazone, and St. John’s wort). In addition, the following drugs may not be co-administered with solithromycin in this trial due to the potential for adverse drug-drug interaction: digoxin, colchicine, midazolam, quinidine, ergotamine, dihydroergotamine, astemizole, and alfentanil.
9.Breastfeeding females
10. Females of childbearing potential (those with menarche and/or thelarche [beginning of breast development]) and sexually active males who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol. (Section 8.3.3)
11.Positive pregnancy test in females of childbearing potential
12.History of intolerance or hypersensitivity to macrolide antibiotics
13. Patient with phenylketonuria

Study & Design

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