Adolescents and Children with Suspected or Confirmed Bacterial Infection MedDRA version: 19.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Solithromycin
Product Code: CEM-101
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: SOLITHROMYCIN
CAS Number: 760981-83-7
Current Sponsor code: CEM-101
Other
Sponsors
Cempra Pharmaceuticals, Inc.
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.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: The PK population for analysis will be defined as all patients who received at least 1 dose of study drug and have at least 1 evaluable PK sample. The safety population for analysis will be defined as all patients who received at least 1 dose of study drug. Interim Analyses: Interim safety analyses will be performed after approximately 4 patients are enrolled in an age group. Enrollment will continue while interim safety analyses are ongoing to complete 8 patients in each cohort. Interim PK analyses will be performed as needed. If interim safety or PK analyses suggest dosing modifications or additional data are required, additional patients may be enrolled up to a maximum of 12 patients in each cohort.;Main Objective: • To determine the PK profile of solithromycin in a pediatric population with a suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active. • To determine the safety of intravenous (IV) and oral (PO) solithromycin in a pediatric population with suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active. ;Secondary Objective: To validate solithromycin concentrations in dried blood spots.;Primary end point(s): PK profile of solithromycin in a pediatric population with a suspected or confirmed bacterial infection safety of intravenous (IV) and oral (PO) solithromycin in a pediatric population with suspected or confirmed bacterial infection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To validate solithromycin concentrations in dried blood spots.;Timepoint(s) of evaluation of this end point: Day 1 and Days 3–5 | — |
Countries
Bulgaria, United States
Contacts
Public ContactLilly Boneva
PSI Pharma Support
Outcome results
None listed