A Single-dose, Open-Label, Multi-center Study to Assess the Safety and Preliminary Efficacy of PRF 110 (Formerly LNP) in Open Herniorrhaphy Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Incidence of treatment emergent adverse events (safety and tolerability).
研究概览
简要总结
LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the Pharmacokinetic (PK) profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
详细描述
LNP is new extended release (ER) oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds. The formulation is designed to slowly release the ropivacaine over 36-72 hours. By providing local analgesia over a long time span, the need for systemic analgesics is expected to be reduced and hospital stays may be shortened. The purpose of this study is to determine the ease of usage and administration of LNP in the surgical setting, to follow the PK profile of LNP over 72 hours and evaluate the duration of analgesia witnessed in the surgical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects between 18-70 years of age who are scheduled to undergo open one sided herniorrhaphy surgery;
- •Subjects have a BMI of less than 30 kg/m2;
- •Subjects are in good physical health (other than the need for the surgical procedure) as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;
- •Subjects must agree to refrain from ingesting any analgesic medication for at least 2 days (or 5 half-lives of the analgesic drug) prior to surgery; refrain from alcohol and excessive caffeine intake on the day of surgery and during 72 hours after surgery;
- •Subject must be capable of reading, comprehending, and signing the informed consent form;
排除标准
- •Subjects with a history of melena or any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders;
- •Subjects with a history of any type of cancer within 5 years of surgery;
- •Subjects with any history of alcohol or substance abuse;
- •Subjects that have a history of uncontrolled hypertension;
- •Subjects with a known hypersensitivity to any local anesthetic drug;
- •Subjects with a hemoglobin concentration of less than 10.0 g/dL;
- •Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
- •Subjects with atrial fibrillation/flutter, an inserted pacemaker, or complete left bundle branch block (LBBB) on ECG; or myocardial infarction within 6 months prior to surgery;
- •Subjects with a clinically significant abnormal ECG at screening;
- •Subjects with any condition or history judged by the Investigator to place the subject at increased risk;
- •Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
- •Subjects who have used an investigational drug within 30 days prior to entering the study;
- •Subjects who have donated blood within 3 months prior to the start of the study;
- •Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study;
研究组 & 干预措施
Application of PRF110- oily solution
Post operative application of new extended release PRF110- oily solution (Ropivacaine)
干预措施: PRF110- oily solution (Ropivacaine) (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (safety and tolerability).
时间窗: 72 hours
All adverse events (AE) reported by the subjects will be recorded throughout the trial period
次要结局
- Post-operative Pain intensity(72 hours)