EUCTR2010-023369-23-ES进行中（未招募）1 期
FIRST-IN-PATIENT STUDY TO ASSESS THE SAFETY ANDTOLERABILITYAND TO EXPLORE THE POTENTIAL THERAPEUTIC EFFICACY OF A NOVELGLUTAMATE MODULATOR AS MONOTHERAPY AND AS ADD-ON THERAPYIN PATIENTS WITH SCHIZOPHRENIA - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •1. Male or female between 18 and 65 years of age, inclusive
- •2. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI =
- •weight/height2)
- •3. Medically stable on the basis of physical examination, medical history,
- •vital signs and 12-lead ECG performed at screening.
- •4. Medically stable on the basis of clinical laboratory tests performed at
- •screening. If the results of the serum chemistry panel, hematology, or
- •urinalysis are outside the normal reference ranges, the subject may be
- •included only if the investigator judges the abnormalities or deviations
- •from normal to not be clinically significant or to be appropriate and
- •reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the
- •investigator.
- •5. In- or outpatients who have been diagnosed with schizophrenia
- •according to DSM-IV (295.10, 295.20, 295.30, 295.60, 295.90) at least 1
- •year prior to screening.
- •6. Known by the recruiting or referring psychiatrist for at least 12
- •7. Men must agree to use a double barrier method of birth control at
- •each sexual intercourse (at least a condom) and to not donate sperm
- •during the study and for 90 days after receiving the last dose of study
- •8. Women must meet one of the following:
- •? postmenopausal (amenorrhoea for at least 12 months prior to
- •screening or amenorrhoea for at least 6 months prior to screening and
- •follicle stimulating hormone [FSH] concentrations of >40 mIU/mL),
- •? surgically sterile (have had a hysterectomy or bilateral oophorectomy,
- •tubal ligation, or otherwise be incapable of pregnancy),
- •? or if sexually active, be practicing an effective method of birth control
- •(e.g., prescription oral contraceptives, contraceptive injections,
- •contraceptive patch, intrauterine device, double-barrier method [e.g.,
- •condoms, diaphragm, or cervical cap with spermicidal foam, cream, or
- •gel], male partner sterilization) as local regulations permit, before entry,
- •and must agree to continue to use the same method of contraception at
- •least 3 months after the last intake of study drug.
- •9. Women of childbearing potential must have a negative serum
- •pregnancy test at screening and a negative urine pregnancy test at
- •baseline before receiving the study drug.
- •10. Must be able and willing to describe subjective experiences while
- •receiving JNJ-40411813.
- •11. Subjects themselves or the relatives they are living with have to be
- •reachable by phone on a regular basis.
- •12. Must be willing and able to adhere to the prohibitions and
- •restrictions specified in this protocol.
- •13. Must have agreed to frequent blood sampling during the course of
- •14. Subjects (or their legally acceptable representative) must have
- •signed a separate written ICF for pharmacogenomic (DNA) research
- •indicating willingness to participate in Part 1 (genetic analyses related
- •to the study) of the pharmacogenomic component of the study; and
- •indicating either consent or refusal for Part 2 (DNA storage for future
- •research) (where local regulations permit). Subject participation in Part
- •1 is required. Subject participation in Part 2 is optional and refusal to
- •participate in Part 2 will not result in ineligibility for the main study.
- 另有 5 项未显示
排除标准
- •1. A current DSM-IV axis I diagnosis other than schizophrenia
- •2. A DSM-IV diagnosis of substance abuse or dependence within 6
- •months prior to screening evaluation (nicotine and caffeine dependence
- •are not exclusionary; subjects with a positive drug screen at screening
- •may be included provided use does not lead to a DSM-IV diagnosis of
- •substance dependence and subjects should be encouraged to abstain
- •from alcohol and illegal drugs within 3 days prior to Day 1 and at any
- •time during the study)
- •3. Any medical condition that could potentially alter the absorption,
- •metabolism, or excretion of the study medication, such as Crohn's
- •disease, liver disease, or renal disease
- •4. Relevant history of any significant and/or unstable cardiovascular,
- •respiratory, neurologic (including seizures or significant cerebrovascular
- •disorders), renal, hepatic, endocrine, or immunologic diseases
- •5. PANSS score <50 or >120
- •6. Other significant and/or unstable systemic illnesses
- •7. Allergy or hypersensitivity to any known antipsychotic compounds
- •8. Inability to swallow the study medication whole with the aid of water
- •(subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile)
- •9. Subjects who have never been treated with antipsychotics
- •10. Exposure to an experimental drug or experimental medical device
- •within 90 days before screening
- •11. Significant risk of suicidal or violent behavior
- •12. Female subjects who are pregnant or breastfeeding
- •13. Clinically significant abnormal values for clinical chemistry,
- •hematology or urinalysis at screening or admission. It is expected that
- •laboratory values will generally be within the normal range for the
- •laboratory, though minor deviations, which are not considered to be of
- •clinical significance to the investigator, are acceptable. Values of
- •ALT/AST <2 fold the upper limit of normal will be allowed
- •14. Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C
- •antibodies or HIV antibodies at screening
- •15. Clinically significant abnormal physical examination, vital signs or
- •12-lead ECG at screening. Minor deviations in ECG, which are not
- •considered to be of clinical significance to the investigator, are
- •acceptable.
- •16. Clinically significant abnormal observations in ECG defined as:
- •? A confirmed screening visit QTcB interval ?470 msec
- •? A history of additional risk factors for torsades des pointes (e.g. heart
- •failure, hypokalemia, family history of Long QT Syndrome)
- •17. Use of monoamine oxidase inhibitors within 4 weeks or fluoxetine
- •within 5 weeks before screening. Use of all tricyclic antidepressants
- •within 2 weeks before screening
- •18. Use of mood stabilizers (e.g., anticonvulsants and/or lithium) within
- •2 weeks before Day 1.
- •19. Received electroconvulsive therapy within 3 months before
- •20. Have been involuntarily committed to psychiatric hospitalization
- •21. Alcohol dependence and/or illicit drug use
- •22. Any condition that, in the opinion of the investigator, would
- •compromise the well-being of the subject or the study or prevent the
- 另有 7 项未显示
研究者
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