NL-OMON32959已完成不适用
Study to Assess the Pharmacokinetic Drug - Drug Interactions between Atazanavir Plus Ritonavir Coadministered with Voriconazole in Healthy Subjects. - ROMA
Bristol-Myers Squibb0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- 年龄范围
- 18 至 99（—）
入选标准
- •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 and Sex
- •a) Women who are not of childbearing potential (ie, who are postmenopausal or
- •surgically sterile) and men, ages 18 to 45 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/mL
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. 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 or 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
- •2) Medical History and Concurrent Diseases
- •a) Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)
- •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 5 cigarettes per day.
- •k) Recent (within 6 months) drug or alcohol abuse as defined in DSM IV, Diagnostic
- •Criteria for Drug and Alcohol Abuse (Appendix 2).
- •l) Any other sound medical, psychiatric and/or social reason as determined by the
- •investigator.
- •m) Consumption of alcohol within 3 days prior to the first dose of study drug.
- •n) Intractable diarrhea (>= 6 loose stools/day for at least 7 consecutive days) within
- •30 days prior to the first dose of study drug.
- •o) History of any hemolytic disorders (including drug-induced hemolysis).
- •p) History of acute or chronic pancreatitis.
- •q) History of hypochlorhydria or achlorhydria.
- •3) Physical and Laboratory Test Findings
- •a) Men and Women < 40 Kg
- •b) Homozygous CYP2C19 poor metabolizers
- •c) 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.
- •d) Positive urine screen for drugs of abuse.
- •e) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV
- •viral RNA or HIV-1, -2 antibody.
- •f) Liver enzymes (alkaline phosphatase, AST, ALT) above the upper limit of normal
- •at screening or prior to dosing.
- •g) QT interval >= 500 msec, QTcF interval >= 450 msec either at screening or prior to
- •dosing (confirmed by repeat ECG).
- •h) PR interval >= 210 msec, QRS interval >= 120 msec either at screening or prior to
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