Phase I/II Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Single, Hourly-Repeating, Escalating Doses of PER977 Following a Single Subcutaneous Dose of Enoxaparin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
PER977 administration following a single dose of enoxaparin
详细描述
Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be administered following administration of enoxaparin. Serial pharmacokinetic and pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events will be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or current evidence of clinically significant disease. Current evidence of liver function tests or renal function tests greater than the upper limit of normal. The presence of Gilbert's Syndrome is acceptable. Current evidence of QTcF > normal (450±10 msec for males or 470±10 msec for females).
- •History of unexplained syncope
- •Hypersensitivity to enoxaparin sodium, thrombocytopenia with a positive in vitro test to anti-platelet antibody in the presence of enoxaparin sodium, hypersensitivity to heparin or porcine products or any other contraindication to enoxaparin
- •History of major bleeding, trauma, surgical procedure of any type, or vaginal delivery within six months prior to screening
- •History of peptic ulcer, gastrointestinal bleeding or bleeding from hemorrhoids within six months prior to screening
- •History of minor bleeding episodes such as epistaxis, or gingival bleeding within 1 month prior to screening
- •Personal or family history of clotting disorder or abnormality, excessive bleeding, thrombovascular disease or any hematologic disorder involving platelets or clotting abnormalities or any condition requiring treatment with transfusions, or personal history of heparin-induced thrombocytopenia
- •Females with a history of dysfunctional uterine bleeding who have not undergone hysterectomy, including history of menorrhagia, metrorrhagia or polymenorrhea
- •Pregnant or breast-feeding
- •Males with a history of hormone therapy within 3 months prior to screening
- •Administration of any blood product or anticoagulant within 3 months prior to study entry or any non-steroidal anti-inflammatory drug or cyclooxygenase inhibitor within 2 weeks prior to dosing.
- •Taking any type of medication for more than 14 consecutive days within the 4 weeks prior to study entry
- •Positive serologic test for HIV, hepatitis C antibody, or hepatitis B surface antigen
- •Donation of blood or blood products within 56 days prior to screening
- •History of randomization in any prior study of PER977
- •Randomization in any study with an investigational compound or device within 30 days prior to signing informed consent
- •Active drug or alcohol dependence within the prior 12 months or any condition that, in the opinion of the Investigator, would interfere with adherence to study protocol
研究组 & 干预措施
Cohort 1
100 mg PER977 (10 subjects); the dose may be repeated two (2) times after an approximate one (1) hour interval for a maximum total of three (3) doses
干预措施: Placebo (Drug)
Cohort 1
100 mg PER977 (10 subjects); the dose may be repeated two (2) times after an approximate one (1) hour interval for a maximum total of three (3) doses
干预措施: PER977 (Drug)
Cohort 1
100 mg PER977 (10 subjects); the dose may be repeated two (2) times after an approximate one (1) hour interval for a maximum total of three (3) doses
干预措施: enoxaparin (Drug)
Cohort 2
200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses
干预措施: PER977 (Drug)
Cohort 2
200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses
干预措施: Placebo (Drug)
Cohort 2
200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses
干预措施: enoxaparin (Drug)
Cohort 3
300 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour after the initial dose for a maximum of total of two (2) doses
干预措施: PER977 (Drug)
Cohort 3
300 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour after the initial dose for a maximum of total of two (2) doses
干预措施: Placebo (Drug)
Cohort 3
300 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour after the initial dose for a maximum of total of two (2) doses
干预措施: enoxaparin (Drug)
Cohort 4
4 x 25 mg PER977 (10 subjects); study drug will be administered every 30 minutes for a total of 4 doses (cumulative dose of 100 mg PER977)
干预措施: PER977 (Drug)
Cohort 4
4 x 25 mg PER977 (10 subjects); study drug will be administered every 30 minutes for a total of 4 doses (cumulative dose of 100 mg PER977)
干预措施: Placebo (Drug)
Cohort 4
4 x 25 mg PER977 (10 subjects); study drug will be administered every 30 minutes for a total of 4 doses (cumulative dose of 100 mg PER977)
干预措施: enoxaparin (Drug)
结局指标
主要结局
Number of adverse events
时间窗: 1 day
Assessment of the number of subjects who experience adverse events and the number and type of adverse events
次要结局
- Reversal of enoxaparin anticoagulation(1 day)
- Pharmacokinetics of enoxaparin(1 day)
- Pharmacokinetics of PER977 and its metabolite(2 days)