NCT04398329已完成1 期
A Phase 1b/2, Randomized, Blinded, Active-Controlled Study of Escalating Doses of HTX-034 for Postoperative Analgesia in Subjects Undergoing Unilateral, First Metatarsal Bunionectomy With Osteotomy and Internal Fixation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
研究概览
简要总结
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia).
- •Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- •Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives.
排除标准
- •Had contralateral foot bunionectomy in the past 3 months.
- •Has a planned concurrent surgical procedure.
- •Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
- •Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
- •Has received or is taking a contraindicated or prohibited medications.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
- •Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
- •Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
- •Has a history of coronary artery bypass graft surgery within 12 months.
- •Has a history of known or suspected coagulopathy.
- •As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
- •Has uncontrolled anxiety, psychiatric, or neurological disorder.
- •Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- •Has undergone 3 or more surgeries within 12 months.
- •Has a known history of glucose-6-phosphate dehydrogenase deficiency.
- •Has any of the following laboratory abnormalities during Screening (1 retest permitted):
- •Severe liver function impairment.
- •Severe kidney function impairment.
- •Platelet count <100,000/μL, hemoglobin <12 g/dL, or hematocrit <35%.
- •Has a body mass index (BMI) >39 kg/m2.
研究组 & 干预措施
Phase 1b (Cohort 1)
Experimental
Fixed dose of HTX-034.
干预措施: HTX-034 (Drug)
Phase 1b (Cohort 2)
Experimental
Individualized dose of HTX-034.
干预措施: HTX-034 (Drug)
Phase 2 (Expansion): Low Dose
Experimental
Fixed dose of HTX-034.
干预措施: HTX-034 (Drug)
Phase 2 (Expansion): High Dose
Experimental
Individualized dose of HTX-034.
干预措施: HTX-034 (Drug)
Phase 1b and Phase 2
Active Comparator
Bupivacaine HCl.
干预措施: Bupivacaine HCl (Drug)
结局指标
主要结局
Incidence of Treatment-emergent adverse events (TEAE's) (Phase 1B)
时间窗: 42 days
Mean area under the curve (AUC) of the NRS scores through 72 hours (AUC0-72) for the pooled Phase 1b and Phase 2
时间窗: 7 days
次要结局
- Maximum plasma concentration (Cmax) of HTX-034(29 days)
- Time of maximum plasma concentration (Tmax) of HTX-034(29 days)
- Area under the concentration-time curve from Time 0 to the time of the last quantitative concentration (AUClast) of HTX-034(29 days)
- Area under the concentration-time curve from Time 0 extrapolated to infinity (AUCinf) of HTX-034 (Phase 1B)(22 days)
- Mean AUC of the NRS pain intensity scores(7 days)
- Apparent terminal half-life (t½) of HTX-034 (Phase 1B)(22 days)
- Proportion of subjects who are opioid-free(14 days)
- Incidence of serious adverse Events (SAE's)(42 days)
- Total postoperative opioid consumption (in IV Morphine Milligram Equivalents)(7 days)
研究者
研究点 (8)
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