Tedizolid PK/Safety study in children 2-12 years

Phase 1

• Conditions: Treatment or prophylaxis against Gram-positive infections; MedDRA version: 20.1 Level: LLT Classification code 10053021 Term: Gram-positive bacterial infection System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-004595-29-GB
• Lead Sponsor: Cubist Pharmaceuticals, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-20
• Study Completion: 2018-12-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

1. Aged 2 to <12 years at the time of consent
2. Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity
3. Weight >5th percentile and <95th percentile based on age
4. Stable condition as determined from medical history, physical examination, ECG (minimally 5-lead), vital signs, and clinical laboratory evaluations
5. No clinically significant ECG abnormalities in the judgment of the Investigator
6. Serum creatinine within 1.5 × upper limit of reference range based on age
7. Females must be pre-menarchal, abstinent, or practicing an effective method of birth control
8. Negative blood or urine beta-human chorionic gonadotropin pregnancy test (if urine test is used, it must be high sensitivity [i.e., able to detect 10 mIU/mL ß-hCG]) at the Screening Visit (post-menarchal females only)
9. Subjects and parents must be willing to adhere to the prohibitions and restrictions specified in this protocol
10. Parents or subjects’ LAR able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children capable of understanding the nature of the study (typically =7 years old)
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator
2. Use of rifampin within 14 days prior to study drug administration
3. Use of ranitidine, cimetidine, and antacids for subjects in Part B (oral administration) from 24 hours prior to study drug administration and throughout the study
4. Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease
5. History of drug allergy or hypersensitivity to oxazolidinones
6. Pregnant or breast feeding
7. Significant blood loss (=5% of total blood volume) within 60 days before the Screening Visit
8. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject’s ability to complete and/or participate in this clinical study
9. Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug
10. Need for oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. (Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.)
11. Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study

Study & Design

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