A Phase 2 Open-Label Study of the Pharmacokinetics (PK) and Safety of HTX-011 Administered Postpartum to Women Undergoing a Planned Caesarean Section
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer
研究概览
简要总结
This is a Phase 2, open-label study to evaluate the PK and safety of HTX-011 in women undergoing a planned C-section.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Is expected, at the time of Screening visit, to deliver a single neonate.
- •Is scheduled to undergo a planned C-section surgery with a low transverse skin incision (eg, Pfannenstiel).
- •Has American Society of Anesthesiologists (ASA) Physical Status of I, II, or III.
- •Agrees to practice abstinence or use double-barrier contraception in the event of sexual activity and commits to the use of an acceptable form of birth control for 30 days after HTX-011 administration.
- •Agrees to refrain from the use of breast milk from this pregnancy in any manner.
排除标准
- •Has planned to breastfeed her neonate at any time during the 28-day period after HTX-011 administration.
- •Has had a prior full-term pregnancy with unsuccessful breast milk expression.
- •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 been administered bupivacaine within 5 days prior to the scheduled surgery.
- •Has been administered any local anesthetic within 72 hours prior to the scheduled surgery.
- •Has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug.
- •Has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control.
- •Has taken any NSAIDs within least 10 days prior to the scheduled surgery.
- •Has current significant placental abnormality/complications including, but not limited to, placenta previa or placenta accreta.
- •Has a medical condition such that, in the opinion of the Investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments.
- •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 a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
- •Previously participated in an HTX-011 study.
- •Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives.
- •Weight is <50 kg at the time of Screening visit.
- •In the Investigator's judgment, subject is likely to have been morbidly obese prior to her pregnancy.
研究组 & 干预措施
Treatment Group 1
A single dose of HTX-011 administered via instillation into the surgical site.
干预措施: HTX-011 (Drug)
Treatment Group 1
A single dose of HTX-011 administered via instillation into the surgical site.
干预措施: Luer Lock Applicator (Device)
Treatment Group 2
A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
干预措施: HTX-011 (Drug)
Treatment Group 2
A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
干预措施: Luer Lock Applicator (Device)
Treatment Group 2
A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
干预措施: Ibuprofen (Drug)
Treatment Group 2
A single dose of HTX-011 administered via instillation into the surgical site and a scheduled non-opioid multimodal analgesic (MMA) regimen.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of bupivacaine, meloxicam, dimethyl sulfoxide (DMSO) and HTX-011 polymer
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in milk of bupivacaine, meloxicam, DMSO and HTX-011 polymer
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Amount of analyte excreted in breast milk over time (Ae)
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Fraction of dose excreted in breast milk over time (Fe)
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Time of maximum plasma concentration (Tmax) of bupivacaine, meloxicam, DMSO and HTX-011 polymer
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
Half life (t1/2) in plasma of bupivacaine, meloxicam, DMSO and HTX-011 polymer
时间窗: Day 1 to Day 16 for Cohort 1; Day 1 to Day 11 for Cohort 2
次要结局
- Mean area under the curve of the NRS pain scores through 72 hours (AUC0-72).(72 hours)
- Incidence of treatment-emergent adverse events (TEAEs).(28 Days.)