NCT02108106已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Safety, Pharmacokinetic and Pharmacodynamic Study of Orally Administered AG-348 in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending oral doses of AG-348 to evaluate the safety and tolerability of a single oral dose of AG-348, the pharmacokinetics (PK) of a single dose of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female subjects 18 - 60 years, in good general health who are able to understand consent and complete all study procedures.
- •Female subjects of non-child bearing potential (surgically sterile or post-menopausal as confirmed by age [over 50 years], amenorrhea for 12 consecutive months and FSH).
- •Male subjects who are not vasectomized must agree to use contraception up to 30 days after dosing.
- •Subjects with body weight ≥50 kg; BMI ≥18.5 and ≤32 kg/m
- •Subjects who are non-smokers and have not used nicotine containing products for at least 3 months prior to screening.
- •Subjects must be willing to refrain from caffeine- or xanthene containing products (chocolate) prior to dosing through 72 hours after dosing.
- •Subjects must agree to refrain from strenuous exercise prior to admission through final visit.
- •Subjects must refrain from use of alcohol starting 7 days prior to admission through final visit.
- •Subjects must agree not to donate blood products for duration of study participation.
排除标准
- •Subjects who have previously received AG-
- •Subjects with clinically relevant screening laboratory tests.
- •Female subjects of childbearing potential.
- •Male subjects with QTcF interval ECG > 450 msec,or female subjects with QTcF interval ECG > 470 msec.
- •Subjects with a history of a serious mental illness.
- •Subjects with a clinically relevant medical history or pre-existing medical condition that would interfere with the absorption, metabolism or excretion of the study drug.
- •Subjects with a history of any primary malignancy (cancer). Exceptions are certain skin cancers, cervical cancer in situ or other cancers that have been curatively treated without evidence of disease for a minimum of 1 year.
- •Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
- •Subjects who are positive for hepatitis B, hepatitis C or HIV.
- •Subjects who have undergone surgery 6 months prior to screening.
- •Subjects who have a history of illicit drug use or alcoholism within the last year.
- •Subjects who are participating in other concurrent clinical trial of an investigational drug, or have received another investigational agent within the last 2 months.
- •Subjects with any conditions which would make the subject unsuitable for enrollment, or could interfere with the subject's participation in or completion of the study.
研究组 & 干预措施
AG-348
Experimental
Single oral dose of AG-348
干预措施: AG-348 (Drug)
Placebo
Placebo Comparator
Single oral dose of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 11 days
Incidence of adverse events and descriptive statistics for safety laboratory parameters, physical exam findings, vital signs and ECGs.
次要结局
- Pharmacodynamic (PD) relationship of AG-348 and metabolic biomarkers(4 days)
- Pharmacokinetics of AG-348(4 days)
研究者
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