NCT06011317已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EDG-7500 in Healthy Adults
适应症
干预措施
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-7500 are to:
- Learn about the safety of EDG-7500 after a single and multiple doses in healthy adults
- Learn about how EDG-7500 is tolerated after a single and multiples doses in healthy adults
- Evaluate the amount of EDG-7500 is in the blood and urine after single and multiple doses in healthy adults
- Evaluate the effect of a meal on the amount of EDG-7500 that is in the blood in healthy adults
- Evaluate whether the amount of EDG-7500 in the blood is similar for the suspension and tablet forms of EDG-7500 in healthy adults
Participants will receive a single or multiple doses of EDG-7500 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
- Treatment
- 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 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 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. Alcohol consumption > 14 drinks per week for males (7 for females). Positive screen for drugs of abuse or alcohol or cotinine test at Screening or Admission.
- •Additional protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
Experimental
Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years
干预措施: EDG-7500 (Drug)
Part A: Healthy Volunteer (Ages ≥ 18 to < 60 years) Single Ascending Dose
Experimental
Single oral ascending dose in healthy volunteers ages ≥ 18 to < 60 years
干预措施: Placebo (Drug)
Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
Experimental
Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years
干预措施: EDG-7500 (Drug)
Part B: Healthy Volunteer (Ages ≥ 18 to < 60 years) Multiple Ascending Doses
Experimental
Multiple oral ascending doses in healthy volunteers ages ≥ 18 to < 60 years
干预措施: Placebo (Drug)
Part D: Healthy Volunteer Food Effect and Relative Bioavailability
Experimental
Crossover food effect (fed versus fasted) single oral dose in healthy volunteers and relative bioavailability of liquid versus solid formulation
干预措施: EDG-7500 (Drug)
结局指标
主要结局
Safety: incidence of treatment-emergent adverse events
时间窗: Up to 25 days of monitoring
To assess the safety and tolerability of EDG-7500 when administered as single and multiple doses
次要结局
- Determination of renal clearance as measured by CLr(Up to 25 days of monitoring)
- Determination of pharmacokinetic parameters as measured by t1/2(Up to 25 days of monitoring)
- Determination of pharmacokinetics parameters as measured by Tmax(Up to 25 days of monitoring)
- Determination of pharmacokinetic parameters as measured by AUC(Up to 25 days of monitoring)
- Determination of pharmacokinetic parameters as measured by Cmax(Up to 25 days of monitoring)
研究者
研究点 (1)
Loading locations...
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