EUCTR2015-002780-42-Outside-EU/EEA进行中（未招募）不适用
A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, andPharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old AdolescentPatients - Pharmacokinetic (PK) Study of Oral and IV TR-701 FA in Adolescent Patients
Trius Therapeutics0 个研究点目标入组 20 人开始时间: 2015年6月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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
- •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
- •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
研究者
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