A Single Ascending Dose Study for the Evaluation of the Effects of LY3039478 on the QT/Corrected QT Interval in Healthy Subjects and Pilot Relative Bioavailability
概览
- 阶段
- 1 期
- 干预措施
- Placebo
- 疾病 / 适应症
- Healthy
- 发起方
- Eli Lilly and Company
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A
- 状态
- 已完成
- 最后更新
- 8个月前
概览
简要总结
The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Participants will receive both formulations of LY3039478, by mouth, over the course of the study. Both parts of the study will also explore how much LY3039478 gets into the bloodstream and how long it takes the body to get rid of it. Information about any side effects will also be collected. Participants may only enroll in one part. The study will last at least 33 days, not including screening. Screening must be performed up to 30 days before enrollment.
Part B was added by protocol amendment approved in April, 2016.
研究者
入排标准
入选标准
- •Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)
排除标准
- •Known allergies to LY3039478, related compounds or any components of the formulation
- •Have previously received LY3039478
- •Smokers or who have stopped smoking less than 3 months prior to enrollment
研究组 & 干预措施
Part A: Placebo
Single oral dose of placebo administered in one of three study periods
干预措施: Placebo
Part A: LY3039478 Capsule Formulation (Formulation 3)
Escalating single oral dose of 25 milligram (mg), 50 mg, and 75 mg capsule formulation (formulation 3) LY3039478 administered in two of three study periods
干预措施: LY3039478 Capsule Formulation (Formulation 3)
Part B: LY3039478 Drug-In Capsule (Reference, Formulation 1)
Single oral 50 mg dose of drug-in capsule (reference, formulation 1) LY3039478 administered in one of two study periods
干预措施: LY3039478 Drug-in Capsule (Reference, Formulation 1)
Part B: LY3039478 Formulated Capsule (Test, Formulation 3)
Single oral 50 mg dose of formulated capsule (test, formulation 3) LY3039478 administered in one of two study periods
干预措施: LY3039478 Formulated Capsule (Test, Formulation 3)
结局指标
主要结局
Pharmacokinetics (PK): Mean Time-Matched Difference in Placebo-Adjusted QTcF Interval With Time Matched Concentrations Between LY3039478 Capsule Formulation (Formulation 3) Part A
时间窗: Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose
PK: mean time-matched difference in QTcF interval with time-matched concentrations between LY3039478 capsule formulation (formulation 3) compared to placebo. Analyses of QTcF was assessed by the mean change in QTcF as a function of plasma drug concentration. Triplicate measures at each time point was averaged prior to analysis. The primary analysis was based on the time-matched placebo-adjusted QTcF (ΔQTcF) for each time point, which was calculated by subtracting each participant's time-matched placebo QTcF from their QTcF results after receiving LY3039478. The relationship between plasma concentrations of LY3039478 and ΔQTcF was evaluated using a linear mixed-effects modeling approach. The response variable was ΔQTcF, and concentrations was fitted as a fixed effect with participants as a random effect. The regression slope was presented with the unit in "milliseconds per nanogram per milliliter" abbreviated as "ms/ng/mL".
次要结局
- PK: AUC(0-∞) of the 2 Formulations of LY3039478 Part B(Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose)
- PK: Cmax of LY3039478 Capsule Formulation (Formulation 3) Part A(Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose)
- PK: Cmax of the 2 Formulations of LY3039478 Part B(Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose)
- PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3039478 Capsule Formulation (Formulation 3) Part A(Predose, 0.5, 1, 2, 3, 4, 6, 8,12, 24, 36, 48 Hours Postdose)