A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events
研究概览
简要总结
This is a Phase 1, single center, single-ascending dose, randomized study
详细描述
Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
排除标准
- •Current significant medical condition, laboratory abnormality, or psychiatric illness
- •History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions
- •PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval > 450 msec
- •Elevated liver function tests greater than twice the upper limit of normal
- •Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
- •Urinalysis positive for protein or glucose
- •A positive screen for alcohol, drugs of abuse, or tobacco use.
- •Inability to comply with food and beverage restrictions during study participation
- •Donation or blood collection or acute loss of blood prior to screening
研究组 & 干预措施
CTP-730, 5 mg
oral suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 5 mg
oral suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 10 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 40 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 10 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 20 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 20 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 30 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 30 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 40 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 50 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 50 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
CTP-730, 60 mg
Oral Suspension, once daily.
干预措施: CTP-730 (Drug)
CTP-730, 60 mg
Oral Suspension, once daily.
干预措施: Placebo for CTP-730 (Drug)
结局指标
主要结局
Number and severity of adverse events
时间窗: 3 days
Pharmacokinetics parameters
时间窗: 96 hours
Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose
次要结局
未报告次要终点