A Single Ascending Dose and Relative Bioavailability Study of LY2940680 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
研究概览
简要总结
This study involves 2 parts, Part A and Part B. The purpose of Part A is to evaluate the safety and side effects of LY2940680 in healthy participants. Part A will involve two groups of participants, each taking up to two single doses of LY2940680 at different dose levels. There is a minimum 14 day washout period between each of the participant's doses. The purpose of Part B is to study how much of the study drug, in capsule or tablet form, gets into the bloodstream and how long the body takes to get rid of it. In addition, the effect of food and a proton pump inhibitor (PPI) on LY2940680 will be studied. Part B will involve one group of participants who will take four single doses of 100 milligrams (mg) LY2940680. There is a minimum 7 day washout period between doses. Participants may only enroll in one part. Screening is required within 28 days prior to the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, 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 sterile males or surgically sterile females or postmenopausal females, as determined by medical history and physical examination
- •Body mass index of 18.5 to 32.0 kilograms per meter square (kg/m^2)
- •Have clinical laboratory test results within normal reference range
- •Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site
- •Prepared to eat an entire high fat breakfast
排除标准
- •Are currently enrolled in, have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
- •Have known allergies to LY2940680, related compounds or any components of the formulation, or known allergies to lansoprazole (Part B only)
- •Have previously completed or withdrawn from this study or any other study investigating LY2940680, and have previously received the investigational product. Participants in Part A are not allowed to participate in Part B
- •Have an abnormality in the 12-lead electrocardiogram (ECG)
- •Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data (cholecystectomy or appendectomy are allowed if surgery at least 6 months prior to screening)
- •Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Show evidence of hepatitis C and/or positive hepatitis C antibody
- •Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- •Have used or intend to use over-the-counter or prescription medication within 14 days prior to dosing or during the study. Exception: participants may continue hormone replacement therapy (HRT; estrogen)
- •Use of herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or Starfruit within 7 days prior to dosing or during the study
研究组 & 干预措施
LY2940680 Tablet Fed (Part B)
100 mg LY2940680 given once orally as a tablet (test formulation) in fed state following a standardized, high-fat breakfast in 1 of 4 study periods
干预措施: LY2940680 Tablet (Test) (Drug)
LY2940680 (Part A)
Single escalating dose (50 mg up to 400 mg) of LY2940680 given once orally in up to 2 of 2 study periods
干预措施: LY2940680 Capsule(s) (Reference) (Drug)
Placebo (Part A)
Placebo given once orally in up to 1 of 2 study periods
干预措施: Placebo Capsule(s) (Drug)
LY2940680 Capsule Fasted (Part B)
100 mg LY2940680 given once orally as a capsule (reference formulation) in fasted state in 1 of 4 study periods
干预措施: LY2940680 Capsule(s) (Reference) (Drug)
LY2940680 Tablet Fasted (Part B)
100 mg LY2940680 given once orally as a tablet (test formulation) in fasted state in 1 of 4 study periods
干预措施: LY2940680 Tablet (Test) (Drug)
LY2940680 Tablet Fasted + PPI (Part B)
30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods
干预措施: LY2940680 Tablet (Test) (Drug)
LY2940680 Tablet Fasted + PPI (Part B)
30 mg lansoprazole (PPI) given orally once daily for 7 days. One hour after last dose, 100 mg LY2940680 given orally once as a tablet (test formulation) in fasted state in 1 of 4 study periods
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Number of Participants With 1 or More Adverse Events (AEs) or Any Serious AEs
时间窗: Baseline through study completion (up to 4 weeks in Part A and 8 weeks in Part B)
Data presented are the number of participants with AEs or any serious AEs (SAEs) regardless of causality. A summary of non-serious AEs is located in the Reported Adverse Events section.
Part B: Pharmacokinetics: Maximum Observed Concentrations (Cmax) of LY2940680 Test and Reference Formulation
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 hours after administration of study drug
The Cmax of 100-milligram (mg) LY2940680 capsule (reference formulation) and 100-mg LY2940680 tablet (test formulation) in fasted and fed state, and with lansoprazole during Part B of the study.
次要结局
- Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)](Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug)
- Part B: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)](Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug)
- Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Infinity [AUC(0-∞)](Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug)
- Part A: Pharmacokinetics: Maximum Observed Drug Concentration (Cmax)(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug)
- Part B: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 and 96 hours after administration of study drug)
- Part A: Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax)(Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug)
- Part A: Pharmacokinetics: Area Under the Curve From Time Zero to Time T, Where T is the Last Time Point With a Measurable Concentration [AUC(0-tlast)](Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours after administration of study drug)