2025-522916-17-00招募中1 期
Phase 1, Open-Label, single arm (Non-comparator) Study to Evaluate the Pharmacokinetics and Safety of a Single Dose of Oral Gepotidacin in Addition to Antibacterial Standard of Care in Pediatric Participants from 2 to less than 12 years of age with a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis with Antibiotics
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 5
- 主要终点
- •AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin.
研究概览
简要总结
To determine the plasma PK parameters of gepotidacin following a single oral dose in study participants
研究设计
- 分配方式
- Na
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants having ≥2 to <12 years of age at the time of signing the informed consent/assent and have a body weight >=10 kilograms (kg).
- •Participants receiving SoC antibacterial therapy for a confirmed/suspected infection or for prophylaxis AND is able to take a single dose of the powder for oral suspension formulation of gepotidacin after a meal.
- •Participants either hospitalized or in an overnight clinic. Participant is expected to be in hospital/clinic for at least 24 hours post administration of study intervention. Participant has an indwelling venous catheter in place as part of the clinical SoC.
- •Male or female according to their reproductive organs at birth.
- •Pregnancy testing is required as appropriate for the age, sexual activity, and sexual maturity of pediatric participants and as required by local regulations. Investigator should apply clinical judgment.
- •A female participant is eligible to participate if she is a WOCBP who is not pregnant as confirmed by a high sensitivity serum or urine pregnancy test at baseline (Day 1) regardless of current or prior contraception use or abstinence, is not breastfeeding, or is not a WOCBP.
- •Participant LAR(s) who has the ability to understand, agree to, and sign the informed consent form before initiation of any protocol-related procedures; participant has the ability to give documented assent.
- •Participant and participant’s LAR are willing and able to comply with study instructions, study visits, and procedures.
排除标准
- •Participants having a BMI-for-age that is less than the 5th percentile or greater than the 95th percentile based on the CDC percentiles. [NCHS Growth Charts].
- •The participant has an ALT value >2 × ULN.
- •The participant has a total bilirubin >1.5xULN; Participants with Gilbert’s syndrome can be included with total bilirubin >1.5xULN as long as direct bilirubin is 1mg/kg/day of prednisolone or equivalent for >1 week or 0.5-<1mg/kg/day prednisolone or equivalent for >2 weeks. Participants aged ≥6 years with a known CD4 count of <200 cells/mm3, and participants aged <6 years with a known CD4 count of <500 cells/mm3 are to not be enrolled.
- •The participant has any of the following medical condition that requires medication that may be impacted by inhibition of acetylcholinesterase, such as: Poorly controlled asthma or obstructive pulmonary disease at baseline and, in the opinion of the investigator, not stable on current therapy; Active peptic ulcer disease; Juvenile Parkinson disease; Juvenile Myasthenia gravis.
- •The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
- •The participant is taking QT-prolonging drugs or drugs known to increase the risk of TdP per the ww.crediblemeds.org. “Known Risk of TdP” category at the time of the Baseline Visit, which cannot be safely discontinued from the Baseline Visit (Day 1) through 7 (+3) days after the single dose of study intervention; or the participant is taking a strong CYP3A4 inhibitor.
- •The participant has a mean triplicate QTc >450 msec or a mean triplicate QTc >480 msec for participants with complete bundle branch block.
- •The participant has a documented or recent history of uncorrected hypokalemia within the past 3 months.
- •The participant plans to use any of the prohibited medications or nondrug therapies from the Baseline Visit through Follow-up Visit at 7 ±3 days after the single dose of study intervention.
- •The participant has received a prohibited medication within 14 days or 5 half-lives prior to gepotidacin administration, whichever is longer.
- •The participant has been previously enrolled in this study or has previously been treated with gepotidacin.
- •The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 halflives prior to gepotidacin administration, whichever is longer
- •The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
- •If the child is being breastfed: There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother; The breastfeeding mother is taking any medication or any substances containing any of the medications included in the prohibited medication list with known or unknown lactation excretion.
- •The participant has severe hepatic organ dysfunction.
研究组 & 干预措施
null, null
Test
干预措施: null, null (Drug)
结局指标
主要结局
•AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin.
•AUC from time zero to the time of the last quantifiable concentration (AUC[0-t]) of gepotidacin.
•Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin.
•Area under the concentration-time curve from time zero extrapolated to infinite time (AUC[0-inf]) of gepotidacin.
•Maximum observed plasma concentration (Cmax) of gepotidacin.
•Maximum observed plasma concentration (Cmax) of gepotidacin.
•Apparent oral clearance (CL/F) of gepotidacin.
•Apparent oral clearance (CL/F) of gepotidacin.
•Apparent volume of distribution (Vz/F) of gepotidacin.
•Apparent volume of distribution (Vz/F) of gepotidacin.
•Terminal phase half-life (t1/2) of gepotidacin.
•Terminal phase half-life (t1/2) of gepotidacin.
次要结局
- •Number of participants with Adverse events (AEs), Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs);
- •Change from baseline in vital signs: Temperature;
- •Change from baseline in vital signs: Blood Pressure;
- •Change from baseline in vital signs: Pulse Rate;
- •Change from baseline in Electrocardiogram (ECG).
研究者
EU GSK Clinical Trials Call Center
Scientific
Glaxosmithkline Research & Development Limited
研究点 (5)
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