NCT07511816招募中2 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of a Single Oral Dose of LY4515100, in Participants Experiencing Moderate-to-Severe Acute Pain Following Surgical Removal of Impacted Third Molars
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Change from Baseline in Self-Reported Pain Intensity
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²) inclusive.
- •Participant requires extraction of 2 or more third molars, including 2 mandibular molars with partial or full bony impaction, confirmed by panoramic X-ray.
排除标准
- •Prior dental surgery within 60 days before screening or history of other surgical procedures that could confound surgery or postoperative procedures.
- •Diagnosis of chronic pain conditions that could confound postsurgical pain reporting in the opinion of the investigator.
- •Positive urine drug screen or alcohol test during screening or on the day of surgery.
- •Evidence or history of any other clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, or neurologic diseases, in the opinion of the investigator, within the last 5 years.
- •History of malignancy of any organ system treated or untreated, within 5 years prior to consent. The only exceptions are previous in situ carcinoma of the cervix, localized basal cell carcinoma of the skin, or localized squamous carcinoma of the skin if the participant has been treated and is considered cured.
研究组 & 干预措施
LY4515100
Experimental
Administered Orally
干预措施: LY4515100 (Drug)
Placebo
Placebo Comparator
Administered Orally
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Self-Reported Pain Intensity
时间窗: Baseline, Up to Day 1
次要结局
- Time to Reduction in Pain Intensity as Measured by an 11-Item Numerical Scale(Baseline, Up to Day 1)
- Change in Self-Reported Pain Relief as Measured by 5-Item Categorical Scale(Baseline, Up to Day 1)
- Time to Rescue Medications(Baseline, Up to Day 1)
- Participants Overall Impression of Pain Relief on a Five-Point Scale(Baseline, Up to Day 1)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4515100(Baseline, Up to Day 1)
研究者
研究点 (1)
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