CTRI/2010/091/002966招募中1 期
Effect of Ketoconazole on the Pharmacokinetics of BMS-650032 in Healthy Subjects
Bristol Myers Squibb0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •4.2.1 Inclusion Criteria
- •1) Signed Written Informed Consent
- •a) The signed informed consent form.
- •2) Target Population
- •a) Healthy subjects as determined by no clinically significant deviation from normal
- •in medical history, physical examination, ECGs, and clinical laboratory
- •determinations.
- •b) Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive.
- •BMI = weight (kg)/ [height (m)]2.
- •3) Age, Sex, and Reproductive Status
- •a) Women who are not of childbearing potential (ie. who are postmenopausal or
- •surgically sterile) and men, ages 18 to 49, inclusive
- •Women are considered surgically sterile only if they have undergone a hysterectomy,
- •bilateral tubal ligation, or bilateral oophorectomy. Post menopause is defined as:
- •? Amenorrhea ≥ 12 consecutive months without another cause or
- •? For women with irregular menstrual periods and on hormone replacement therapy
- •(HRT), a documented serum follicle stimulating hormone (FSH) level
- •> 35 mIU/m
排除标准
- •1) Sex and Reproductive Status
- •WOCBP include any female who has experienced menarche and who has not
- •undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
- •or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined
- •? Amenorrhea ≥ 12 consecutive months without another cause or
- •? For women with irregular menstrual periods and on hormone replacement
- •therapy (HRT), a documented serum follicle stimulating hormone (FSH) level
- •> 35 mIU/mL
- •Women who are using oral contraceptives, other hormonal contraceptives
- •(vaginal products, skin patches, or implanted or injectable products), or
- •mechanical products such as an intrauterine device or barrier methods
- •(diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing
- •abstinence or where their partner is sterile (eg, vasectomy) should be
- •considered to be of childbearing potential.
- •b) Women who are pregnant of breastfeeding
- •c) Women with a positive pregnancy test on enrollment or prior to administration of
- •investigational product
- •d) Sexually active fertile men not using effective birth control if their partners are
- •WOCBP or male subject who have sex with women who are unwilling to agree to
- •practice double barrier contraception (ie condom with spermicide) and refrain
- •from donating sperm during study participation and for at least 12 weeks
- •following dosing.
- •2) Medical History and Concurrent Diseases
- •a) At risk for tuberculosis (TB) infection. Specifically subjects with:
- •i) Current clinical, radiographic or laboratory evidence of active or latent TB
- •ii) A history of active TB within the last 3 years, even if it was treated.
- •iii) A history of active TB greater than 3 years ago unless there is documentation
- •that the prior anti-TB treatment was appropriate in duration and type
- •b) Any significant acute or chronic medical illness.
- •c) Current or recent (within 3 months) gastrointestinal disease.
- •d) Any major surgery within 4 weeks prior to study drug administration.
- •e) Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •f) Donation of blood or plasma to a blood bank or in a clinical study (except a
- •screening visit) within 4 weeks prior to study drug administration.
- •g) Blood transfusion within 4 weeks prior to study drug administration.
- •h) Inability to tolerate oral medication.
- •i) Inability to be venipunctured and/or tolerate venous access.
- •j) Smoking more than 10 cigarettes per day.
- •k) A personal history of clinically significant cardiac disease, symptomatic or
- •asymptomatic arrhythmias, syncopal episodes, or additional risk factors for
- •torsades de pointes.
- •l) Recent (within 6 months) drug or alcohol abuse as defined in DSM IV, Diagnostic
- •Criteria for Drug and Alcohol Abuse.
- •m) Any other sound medical, psychiatric and/or social reason as determined by the
- •investigator.
- •3) Physical and Laboratory Test Findings
- •a) Evidence of organ dysfunction or any clinically significant deviation from normal
- •in physical examination, vital signs, ECG or clinical laboratory determinations
- •beyond what is consistent with the target population.
- •b) Any of the following screening or Day 1 laboratory results outside of the ranges
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研究者
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