An Open-Label Study to Evaluate Tissue Distribution, Plasma Pharmacokinetics, Safety, and Tolerability After a Single Intravenous Dose of TNP-2092 in Adult Participants Undergoing Primary Total Hip or Knee Arthroplasty
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Concentration of TNP-2092 in synovial fluid
研究概览
简要总结
This study will investigate TNP-2092 distribution into joint tissues in participants undergoing a total hip arthroplasty (THA) or a total knee arthroplasty (TKA). Tissue distribution is the primary objective, and plasma pharmacokinetics (PK), safety, and tolerability are secondary objectives.
详细描述
This is a Phase 1, open-label study to evaluate the tissue distribution, plasma PK, safety, and tolerability after a single 300 mg intravenous (IV) dose of TNP-2092 administered before induction of anesthesia in adult participants undergoing THA or TKA. Sixteen patients who are scheduled to undergo primary THA or TKA will be enrolled.
The enrolled participants who meet the inclusion/exclusion criteria will receive the study intervention (a single 300 mg IV dose of TNP-2092) 2 hours before induction of anesthesia on Day 1. Tissue samples from bone and synovial fluid will be collected during surgery and analyzed for TNP-2092 and cefazolin concentrations. Plasma samples will be collected on Day 1 and Day 2 for PK analysis. Safety and tolerability information will be collected on Day 1 and Day 2 at the clinical center, on Day 7 by phone, and on Day 14 at a final follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Participants are eligible to be included in the study only if all inclusion criteria are met:
- •Male or females, 18 years of age or older
- •Participants who require primary THA or TKA
- •Body mass index (BMI) >=18 kg/m2 but <=40 kg/m2
- •Capable of giving signed informed consent
排除标准
- •Participants are excluded from the study if any of the following exclusion criteria are met:
- •History or hypersensitivity or intolerability to any of the following drugs: any member of fluoroquinolones, rifamycin, cefazolin or TNP-2092
- •History of known methicillin-resistant Staphylococcus aureus (MRSA) infections
- •Presence of any surgical or medical condition that in the opinion of the principal investigator and the medical monitor that could impact the interpretation of the results of the study;
- •Evidence of significant hepatic, hematologic or immunologic disease;
- •History or evidence of severe renal disease
研究组 & 干预措施
TNP-2092 300mg IV
TNP-2092 for injection 100mg/vial, 300mg, BID, 1 dose
干预措施: TNP-2092 (Drug)
结局指标
主要结局
Concentration of TNP-2092 in synovial fluid
时间窗: 2 hours after infusion
Concentration in ng/mL
Concentration of TNP-2092 in bone
时间窗: 2 hours after infusion
Concentration in ng/g
次要结局
- Rate of adverse event with TNP-2092(Day2, Day7, Day14)
- Plasma PK of a single IV dose of TNP-2092(pre-dose, end of infusion, 1 hours, 3 hous, 6 hours, 12 hours and 24 hours after infusion)