A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-15400 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Safety: incidence of treatment-emergent adverse events
研究概览
简要总结
The purposes of this Phase 1 study of EDG-15400 are to:
- Learn about the safety of EDG-15400 after single and multiple doses in healthy adults
- Learn about how EDG-15400 is tolerated after single and multiples doses in healthy adults
- Evaluate the amount of EDG-15400 in the blood and urine after single and multiple doses in healthy adults
- Evaluate the effect of a meal on the amount of EDG-15400 that is in the blood in healthy adults
- Evaluate whether the amount of EDG-15400 in the blood is similar for the suspension and tablet forms of EDG-15400 in healthy adults
Participants will receive a single or multiple doses of EDG-15400 or a placebo by mouth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent and follow all study procedures and requirements.
- •Healthy male or nonpregnant female, ages ≥18 to <60 years.
- •Body mass index (BMI) ≥18.5 to <35 kg/m2; weight ≥55 kg at Screening.
- •Absence of important health problems and essentially normal physical examination, normal laboratory screening tests, and normal electrocardiogram (ECG) with QTc interval corrected for heart rate using the Fridericia method (QTcF) ≤450 ms.
排除标准
- •Evidence of clinically significant abnormalities or disease.
- •Unless permitted by protocol, use of any prescription medication ≤ 4 weeks or investigational medication ≤ 12 weeks or ≤ 5 half-lives (whichever is longer) of dosing. Use of any non-prescription medication or herbal/nutritional supplement ≤ 5 days prior to dosing.
- •Donation or loss of > 1 unit (450 mL) of blood ≤ 1 month prior to dosing.
- •Females: nursing, lactating, or pregnant.
- •Females: breast implants.
- •Use of nicotine-containing products in the last 6 months prior to dosing.
- •History of substance abuse or dependency or history of recreational drug use within the last 2 years.
- •Alcohol consumption > 14 drinks per week for males (7 for females) within 45 days of screening.
- •Positive screen for drugs of abuse or alcohol or nicotine exposure test at Screening or Admission.
- •Additional protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part C: Healthy Adult (Ages ≥18 to <60 years) Food Effect and Relative Bioavailability
Crossover food effect (fed versus fasted) single oral dose in healthy adults and relative bioavailability of liquid versus solid formulation
干预措施: EDG-15400 (Drug)
Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose
Single oral ascending dose in fasted healthy adults
干预措施: EDG-15400 (Drug)
Part A: Healthy Adult (Ages ≥18 to <60 years) Single Ascending Dose
Single oral ascending dose in fasted healthy adults
干预措施: Placebo (Drug)
Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses
Multiple oral ascending doses once daily in fasted healthy adults
干预措施: EDG-15400 (Drug)
Part B: Healthy Adult (Ages ≥18 to <60 years) Multiple Ascending Doses
Multiple oral ascending doses once daily in fasted healthy adults
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: incidence of treatment-emergent adverse events
时间窗: Up to 45 days of monitoring
To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults
Safety: incidence of treatment-emergent adverse events
时间窗: Up to 25 days of monitoring
To determine the safety and tolerability of EDG-15400 when administered as single and multiple ascending doses to healthy adults
次要结局
- Determination of Tmax(Up to 38 days)
- Determination of Cmax(Up to 38 days)
- Determination of AUC(Up to 38 days)
- Determination of t1/2(Up to 38 days)
- Determination of V/F(Up to 38 days)
- Determination of CL/F(Up to 38 days)
- Determination of CLr(Up to 38 days)
- Determination of V/F(Up to 25 days)
- Determination of Tmax(Up to 25 days)
- Determination of Cmax(Up to 25 days)
- Determination of AUC(Up to 25 days)
- Determination of t1/2(Up to 25 days)
- Determination of CL/F(Up to 25 days)
- Determination of CLr(Up to 25 days)