Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Measurement of Ticagrelor Pharmacokinetics After Drug Administration
研究概览
简要总结
The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event.
详细描述
There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in 10 healthy individuals.
It will test the hypothesis that ticagrelor exposure does not significantly alter platelet mRNA splicing. It will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 70 years-old
- •Speak and understand English
排除标准
- •History of blood clotting/bleeding disorders
- •Current medications that are CYP3A4 inhibitors/inducers
- •Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per FDA recommendations.
- •Diagnosed with arterial or venous thrombosis
- •Active cancer diagnosis
- •Hepatic impairment including active hepatitis infection or cirrhosis
- •Current hormonal contraception
- •Currently taking aspirin or anti-platelet drugs. If patient has recently taken an NSAID, the last dose should have been discontinued based established criteria
研究组 & 干预措施
Healthy Patients
The study design will involve analysis of platelet splicing/activity before and after exposure to a single, 180 mg loading dose of ticagrelor. All subjects will be cardiovascular healthy.
干预措施: Ticagrelor Oral Tablet [Brilinta] (Drug)
结局指标
主要结局
Measurement of Ticagrelor Pharmacokinetics After Drug Administration
时间窗: Comparison made 2.5 hours following drug administration
Drug and its major metabolite levels will be measured by HPLC
Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration
时间窗: Comparison made 2.5 hours following drug administration
As determined by RNAseq analysis
Measurement of the Change in Platelet Activity From Baseline after Drug Administration
时间窗: Comparison made 2.5 hours following drug administration
As determined by the VerifyNow P2Y12 Assay
次要结局
未报告次要终点
研究者
Travis J. O'Brien
Associate Professor of Pharmacology and Physiology
George Washington University