A Phase 1, Open-label Study to Characterize Single and Repeat Dose Pharmacokinetics (Including Food Effect) of Tebipenem-pivoxil-hydrobromide and Its Major Metabolite (SPR1349) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood
研究概览
简要总结
The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History or presence of/significant history of or current cardiovascular (CV), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or study procedures or interfering with the interpretation of data.
- •Past or intended use of over-the-counter or prescription medication including herbal medications within 28 days prior to dosing, with the exception of supplemental vitamins, hormonal medications (contraceptives or hormone-replacement therapy), or occasional oral acetaminophen (not to exceeding 2 g total daily dose).
- •Current enrollment or past participation in another investigational/observational clinical study in which an investigational intervention (e.g., drug, vaccine, invasive device) was administered within the last 30 days, or 5 half-lives whichever is longer.
- •Positive COVID-19 screening test using PCR or antigen assay at Day -1
- •Donation of, or significant blood loss of, more than 500 mL of blood within 56 days prior to dosing.
- •Receipt of a blood transfusion within 1 year prior to enrollment or plasma donation within 7 days prior to dosing.
- •QTc >450 msec.
- •Note: Other inclusion/exclusion criteria may also apply
研究组 & 干预措施
Part A: Cohort 1
Participants will receive TBP-PI-HBr, 900 milligrams (mg) tablets orally, as a single dose under fasted condition on Day 1.
干预措施: TBP-PI-HBr (Drug)
Part A: Cohort 2 (Fasted/Fed)
Participants will receive TBP-PI-HBr, 1200 mg, tablets, orally, as a single dose under fasted and fed conditions on Day 1 and Day 3, as per the assigned crossover sequence.
干预措施: TBP-PI-HBr (Drug)
Part B: Cohort 3
Participants will receive TBP-PI-HBr, 600 mg, orally as a single dose on Day 1, followed by 9 doses every 6 hours from Day 3 through Day 5. (first and ninth dose will be given under fasted conditions).
干预措施: TBP-PI-HBr (Drug)
结局指标
主要结局
Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part A and B: Time to Cmax (Tmax) of TBP in Plasma and Blood
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part A and B: Area Under the Concentration-Time Curve (AUC) Extrapolated to Infinity [AUC(0-inf)] of TBP in Plasma and Blood
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part A and B: AUC From Time Zero to the Time of the Last Evaluable Concentration [AUC(0-t)] of TBP in Plasma and Blood
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part A and B: Amount Excreted in Urine (Ae) of TBP
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part A and B: Fraction of Dose Excreted in Urine (Fe) of TBP
时间窗: Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7
Part B: AUC From Time Zero to 6 Hours Post-dose AUC(0-6) of TBP in Plasma and Blood
时间窗: Pre-dose and at multiple timepoints post-dose up to Day 7
Part B: Ae of SPR1349
时间窗: Pre-dose and at multiple timepoints post-dose up to Day 7
Part B: Fe of SPR1349
时间窗: Pre-dose and at multiple timepoints post-dose up to Day 7
次要结局
- Part B: Tmax of SPR1349 in Plasma(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: Cmax of SPR1349 in Plasma(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: AUC(0-inf) of SPR1349 in Plasma(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: AUC(0-t) of SPR1349 in Plasma(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: AUC(0-6) of SPR1349 in Plasma(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: Plasma AUC Ratio of SPR1349 to TBP(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Part B: Ae Ratio of SPR1349 to TBP(Pre-dose and at multiple timepoints post-dose up to Day 7)
- Parts A and B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Day 21)