A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
研究概览
简要总结
The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK). The study objectives include:
- To evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
- To characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
- To assess the food effect on the PK of a single oral dose of INX-08189
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and post-menopausal (absence of periods for more than 2 years) surgically sterile, or non-pregnant, non-lactating women using a reliable form of contraception (see Inclusion Criteria 9)
- •Age 18 to 65 years, inclusive
- •Normal (no clinically significant abnormalities) laboratory tests (chemistry, hematology and urinalysis)
- •No clinically significant abnormalities on ECG (QTcB interval must be < 450 ms)
- •Weight ≥ 50kg and Body Mass Index (BMI) of 19 to 30, inclusive
- •Negative urine drug screen at screening and on Study Day -1
- •Negative serum βHCG pregnancy test at screening and on Study Day -1 (for all women)
- •Hepatitis B surface antigen, hepatitis C antibody, and HIV antibody negative
- •Agreement to practice a barrier method of birth control plus the use of a spermicide throughout the study period by both male and female subjects (oral contraceptives are not permitted)
- •Able to complete all study visits
- •Signed informed consent form (ICF)
排除标准
- •Any active medical problem for which the subject is being evaluated and/or treated
- •Calculated creatinine clearance (calculated using the IDMS traceable equation for the MDRD value) < 50 mL/min/1.73 m2
- •Regular use of medications, prescription or non-prescription; no medication may be taken within 1 week prior to study dosing
- •Use of alcohol within 48 hours prior to dosing (subjects must also agree to not use alcohol for 96 hours after dosing)
- •Current lactation or breastfeeding
- •Major surgery within 30 days prior to dosing
- •Receipt of an investigational drug within 30 days prior to dosing
- •Donation of blood or plasma within 30 days prior to dosing
- •Any other problem, that in the opinion of the Investigator, will affect the safety of the subject or outcome of the study
研究组 & 干预措施
INX-08189
干预措施: INX-08189 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluate the safety of single ascending oral doses of INX-08189 in healthy subjects
时间窗: periodically over 14 days
Safety will be evaluated on the basis of adverse event (AE) incidence, changes in serum chemistry and hematology values, urinalysis results, and changes in vital signs and in electrocardiogram (ECG) findings.
Characterize the pharmacokinetic (PK) profile of single ascending oral doses of INX-08189 in healthy subjects
时间窗: periodically over 14 days
Including a determination of maximum observed plasma concentration (Cmax), time at which the maximum plasma concentration was observed (Tmax), time at which concentrations are first measurable in the plasma (Tlag), area under the plasma concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-last) and elimination half-life (T 1/2) after single ascending oral doses.
Assess the effect of a high fat meal on the PK parameters
时间窗: periodically over 14 days
The effect of food (standard high-fat meal) on the absorption of INX-08189 will be evaluated
次要结局
未报告次要终点