EUCTR2006-003659-19-GB进行中（未招募）1 期
A Double Blind, Placebo- and Active-Controlled, Randomized, Sequential Group, Multiple Dose Study to Examine the Effect of the CRF1-Receptor Antagonist R317573 on 7.5% CO2-Inhalation Induced Anxiety in Healthy Subjects - Not available
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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) Healthy males and females
- •2) Age between 18 and 45 years, inclusive
- •3) BMI between 18 and 28 kg/m2 inclusive (BMI = weight/height2).
- •4) For males: Willingness to use an adequate contraception for the duration of the study and for 3 months thereafter.
- •5) Female subjects must be postmenopausal (for at least 12 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; have a negative urine pregnancy test at screening and at Day 1.
- •6) A positive response to a 20 minutes CO2 inhalation defined as a score greater than or equal to 2 in at least one of the items: fear of loss of control; anxiety; fear of dying; apprehension/fear in the PSI and/or a score of greater than or equal to 1 of at least 8 of the 34 symptoms in the PSI taken just after the inhalation to assess peak effect.
- •7) Non-smoker or smokes < 5 cigarettes per day.
- •8) No abuse of alcohol defined as an average intake of greater than 21 units per week or 3 units per day. One unit is equivalent to a half pint of beer or 1 measure of spirits or 1 glass of wine.
- •9) Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •10) In order to participate in the pharmacogenomic component, subjects must have signed the informed consent for DNA research indicating whether they do or do not wish to participate in the DNA component of the study (where local regulations permit).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •1) Having cardiovascular disease or a history of cardiovascular disease.
- •2) Having (a history of) migraine or frequent headache.
- •3) Having attacks of hyperventilation.
- •4) Clinically significant abnormal values in TSH measured during the screening period. It is expected that the values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance, are acceptable.
- •5) Clinically significant abnormal values for hematology, clinical chemistry or urinalysis. 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 both the investigator and to the J&JPRD Safety Physician, are acceptable.
- •6) Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening or admission.
- •7) History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the Investigator considers should exclude the subject.
- •8) A history or presence of neurological or psychiatric conditions (e.g. stroke, traumatic brain injury, epilepsy, space occupying lesions, multiple sclerosis, Parkinson’s disease, vascular dementia, transient ischemic attack, schizophrenia, major depression, generalized anxiety disorder, panic attacks, claustrophobia or severe anxiety etc.). Psychiatric illness will be assessed by a neuropsychiatric interview and the medical history.
- •9) Needle or blood phobia.
- •10) Positive urine screen for drugs of abuse (opiates, barbiturates, cannabis, benzodiazepines, cocaine, amphetamines).
- •11) A positive alcohol breath test.
- •12) Serology positive for hepatitis B surface antigen, hepatitis C antibodies or HIV antibodies 1 and 2.
- •13) Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola per day.
- •14) Clinically significant acute illness within 7 days prior to first study drug administration.
- •15) History of relevant drug and/or food allergies.
- •16) Any treatment with corticosteroids either depot or orally within a month first study drug administration.
- •17) Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
- •18) Exposure to any new investigational agent within 90 days prior to the study drug administration.
- •19) Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to study drug administration (not including paracetamol). Corticosteroids within 1 month and contraceptives and stable hormone replacement therapy (HRT) are allowed.
- •20) Psychological and/or emotional problems, which would render the informed consent invalid, or limit the ability of the subject to comply with the study requirements.
- •21) Any condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the subject.
- •22) Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
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