The Relative Bioavailability of a Proposed Phase 2 LY2608204 Test Formulation Compared With the Current Phase 1 LY2608204 Reference Formulation After Administration of a Single Oral 80-mg Dose in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
研究概览
简要总结
The purpose of this study is to compare 2 formulations of the study drug (LY2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a healthy male or a female who cannot become pregnant
- •Must have body mass index (BMI) of 18.5 to 32 kg/m², inclusive
- •Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
- •The veins must be suitable for easy blood collection
- •Must be willing to be available for the whole study and be willing to follow study procedures
- •Must have given written informed consent
排除标准
- •Were in another new drug or medical research study in the last 30 days
- •Have participated in this study or any other study with LY2608204 before
- •Have taken drugs similar to LY2608204 (glucokinase activators) before and was found to be allergic to the drug
- •Have drug allergy to more than 3 types of medications given by injection
- •Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- •Electrocardiogram (ECG) readings are not suitable for the study
- •Are infected with hepatitis B
- •Are infected with human immunodeficiency disease virus (HIV)
- •Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
- •Are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or Seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (CRU)
- •Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- •Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- •Have a history of drug or alcohol abuse
- •Have donated 450 milliliter (mL) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation)
- •The study doctor thinks the subject should not participate for any other reasons
研究组 & 干预措施
LY2608204 Reference, LY2608204 Test
Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods.
干预措施: LY2608204 Reference (Drug)
LY2608204 Reference, LY2608204 Test
Single oral 80 mg dose of LY2608204 reference formulation in period 1; single oral 80 mg dose of LY2608204 test formulation in period 2. There is a washout period of at least 14 days between dosing periods.
干预措施: LY2608204 Test (Drug)
LY2608204 Test, LY2608204 Reference
Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods.
干预措施: LY2608204 Reference (Drug)
LY2608204 Test, LY2608204 Reference
Single oral 80 mg dose of LY2608204 test formulation in period 1; single oral 80 mg dose of LY2608204 reference formulation in period 2. There is a washout period of at least 14 days between dosing periods.
干预措施: LY2608204 Test (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
时间窗: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Area under the concentration versus time curve from zero to infinity \[AUC(0-∞)\] was calculated from the data. The values for AUC were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
Maximum Observed Drug Concentration (Cmax)
时间窗: Predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, 96, 120, 144 and 168 hours
Maximum observed drug concentration (Cmax) was observed from the data. The values for Cmax were log-transformed and analyzed using a linear mixed effects model with fixed factor for formulation, sequence and period, and a random factor for subject.
次要结局
未报告次要终点