Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients

• Conditions: Acute bacterial skin and skin structure infections; MedDRA version: 18.0Level: HLGTClassification code 10040879Term: Skin investigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-002780-42-Outside-EU/EEA
• Lead Sponsor: Trius Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients who met the following criteria were eligible to be included in the study:
1. males and females, between 12 and 17 years of age, inclusive
2. receiving prophylaxis for or had a confirmed or suspected infection with
gram-positive bacteria and receiving concurrent antibiotic treatment with
gram-positive antibacterial activity
3. patient’s weight >5th percentile and <95th percentile for his or her age
4. in stable condition as determined from medical history, physical examination,
12-lead ECG, vital signs, and clinical laboratory evaluations (if the results of the
chemistry, hematology, or urinalysis (UA) tests were outside normal reference
ranges for a patient’s age, the patient could have been included if the Investigator
judged the abnormalities or deviations from normal as not clinically significant or
as related to infection. This determination was recorded in the patient’s source
documents and initialed by the Investigator)
5. no clinically significant ECG abnormalities in the judgment of the Investigator
6. serum creatinine within ±10% of the normal range for the patient’s age
7. females were premenarchal, surgically sterile, abstinent, or practicing an effective
method of birth control (eg, a nonhormonal intrauterine device [IUD] with
spermicide; female condom with spermicide; contraceptive sponge with
spermicide; diaphragm with spermicide; cervical cap with spermicide; a male
sexual partner who agreed to use a male condom with spermicide; a sterile sexual
partner; or prescription oral contraceptives in addition to another approved
method) before entry and throughout the study
8. females had a negative FDA-approved urine or blood ß-human chorionic
gonadotropin pregnancy test at Screening
9. males were either surgically sterile, abstinent, or practicing an effective method of
birth control (eg, double-barrier method; female partner sterilization; female
partner use of prescription oral contraceptives, contraceptive injections, IUD,
contraceptive patch) throughout the study
10. no history of human immunodeficiency virus infection or acquired
immunodeficiency syndrome
11. patients were willing to adhere to the prohibitions and restrictions specified in the
protocol
12. parents or patients’ legally acceptable representative(s) signed an informed
consent document indicating that they understood the purpose of and procedures
required for the study and were willing to have their child participate in the study.
Assent was also required of children capable of understanding the nature of the
study (typically =7 years of age)
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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

Patients who had any of the following criteria were to be excluded from the study:
1. relevant history of seizures, clinically significant cardiac arrhythmia, cystic fibrosis,
moderate or severe renal impairment, or any physical condition that could have
interfered with the interpretation of the study results
2. any acute or chronic condition that, in the opinion of the Investigator, would have
limited the patient’s ability to complete and/or participate in this clinical study
3. physician-diagnosed migraine headaches
4. history of infection with hepatitis or other significant hepatic disease
5. relevant history of drug allergy or hypersensitivity to oxazolidinones
6. liver enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST],
bilirubin) more than 2 times upper limit of normal (ULN)
7. females who were pregnant or breast feeding
8. hormonal implantable, transdermal, or intravaginal (eg, etonogestrel/ethinyl
estradiol vaginal ring) contraceptives could not have been used from 14 days prior
to enrollment until 30 days after Final Visit. Injectable contraceptives were not
permitted from 90 days prior to enrollment until 30 days after Final Visit
9. significant blood loss (300 mL or 5% of total blood volume) within 60 days before
Screening
10. known or suspected hypersensitivity or intolerance to heparin, if an indwelling
catheter (eg, heparin lock) was used
11. any history of drug or alcohol abuse
12. consumption of alcohol-, grapefruit-, caffeine-(excluding regular soda or soft-drinks
but including coffee and energy drinks), or high tyramine-containing foods or
beverages from 24 hours before study drug administration until the last assessment
13. receiving chronic systemic immunosuppressive therapy such as chemotherapy for
cancer or prednisone doses =20 mg per day for =3 of the last 12 months
14. patients who had received an experimental drug or used an experimental medical
device within 30 days or 5 half-lives before Screening
15. use of rifampin, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants,
buspirone, meperidine, selective serotonin reuptake inhibitors (SSRIs), and
serotonin 5-HT1 receptor agonists (triptans) within 14 days prior to dosing
16. use of the following medications within 48 hours before dosing, or planned use
through Final Visit: directly or indirectly acting sympathomimetic agents (eg,
pseudoephedrine, phenylpropanolamine), vasopressive agents (eg, epinephrine,
norepinephrine), dopaminergic agents (eg, dopamine, dobutamine), or
over-the-counter medications containing vasoconstrictive agents; however, use of a
local, cutaneously injected anesthetic containing a small amount of epinephrine was
allowed
17. use of probenecid (all patients) and ranitidine, cimetidine, and antacids for patients
in Part A (oral dose) from 24 hours prior to dosing and throughout the study
18. children of the Investigator or of employees of the Investigator or Study Center

Study & Design

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