EUCTR2005-005022-31-GB进行中（未招募）1 期
Effect of a High-Fat or a Light Meal Relative to Fasting Conditions on the Pharmacokinetics of Atazanavir when Administered with Ritonavir in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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
入选标准
- •1) Signed written informed consent
- •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 30 kg/m2, inclusive.
- •3) Men and women, ages 18 to 50 years inclusive.
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and after the study in such a manner that the risk of pregnancy is minimized.
- •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) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for a period of at least 1 month before and after the study.
- •b) WOCBP using a prohibited contraceptive method within 3 months of first study dose.
- •c) Women who are pregnant or breastfeeding
- •d) Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •2) Medical History and Concurrent Diseases
- •a) Any significant acute or chronic medical illness.
- •b) Current or recent (within 3 months) gastrointestinal disease.
- •c) Any major surgery within 4 weeks of first dose of study drug.
- •d) Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •e) Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of first dose of study drug.
- •f) Blood transfusion within 4 weeks of first dose of study drug.
- •g) Inability to tolerate oral medication.
- •h) Inability to be venipunctured and/or tolerate venous access.
- •i) Recent (within 6 months) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse (see Protocol Appendix 4)
- •j) Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
- •k) Smoking more than 10 cigarettes per day.
- •l) History of nephrolithiasis.
- •m) History of acute or chronic pancreatitis.
- •n) History of any hemolytic disorders.
- •o) Proven or suspected acute hepatitis.
- •p) Known or suspected HIV, HBV or HCV infection.
- •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.
- •b) Positive urine screen for drugs of abuse either at screening or before each dose of study drug.
- •c) Positive blood screen for hepatitis B and/or C antibodies.
- •d) Positive blood screen for HIV-1;-2 antibodies.
- •e) Positive pregnancy test for females.
- •f) Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 80 mL/min.
- •g) Liver enzymes (total bilirubin, alkaline phosphatase, AST, ALT) above the upper limit of normal.
- •h) QTc interval > 450 msec for males or > 470 msec for females.
- •i) Second- or third-degree A-V block or clinically relevant ECG abnormalities.
- •4) Allergies and Adverse Drug Reactions
- •a) History of allergy to atazanavir, ritonavir or related compounds.
- •b) History of any significant drug allergy.
- •c) Inability to tolerate or history of allergy to any of the foods described in the standard light and high-fat meals.
- •5) Prohibited Therapies and/or Medications
- •a) Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug.
- •b) Use of any prescription drugs or over-the-counter acid controllers within 4 weeks of first dose of study drug.
研究者
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