A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
A Phase 1 Open-Label, Single Dose Study to Evaluate the Pharmacokinetics of Gepotidacin in Healthy Lactating Women
This study aims to evaluate the pharmacokinetic of gepotidacin in fed healthy lactating women.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:US GSK Clinical Trials Call Center
- 电话号码:877-379-3718
- 邮箱:GSKClinicalSupportHD@gsk.com
研究联系人备份
- 姓名:EU GSK Clinical Trials Call Center
- 电话号码:+44 (0) 20 89904466
- 邮箱:GSKClinicalSupportHD@gsk.com
学习地点
-
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Nevada
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Las Vegas、Nevada、美国、89113-2235
- 招聘中
- GSK Investigational Site
-
接触:
- US GSK Clinical Trials Call Center
- 电话号码:877-379-3718
- 邮箱:GSKClinicalSupportHD@gsk.com
-
接触:
- EU GSK Clinical Trials Call Centre
- 电话号码:+44 (0) 20 8990 4466
- 邮箱:GSKClinicalSupportHD@gsk.com
-
首席研究员:
- Darin Brimhall
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants must be healthy lactating women, 18 to 50 years of age, inclusive, at Screening.
- Actively breastfeeding or expressing breast milk.
- At least 28 days postpartum with a full milk supply established, and with no persistent complications from delivery (there is no maximal length of time postpartum required).
- Willingness to temporarily discontinue feeding breast milk to infants from dosing through to 72 hours after dosing (approximately 3 days), with the ability to pump and provide reserve milk for bottle feeding prior to the study OR has decided to permanently discontinue breastfeeding but has not started weaning, provided the infant accepts bottle feeding and a sufficient milk supply is maintained by pumping 3 to 4 times daily, considering changes in milk composition during weaning process.
- Is willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. Participants must be able to express milk from each breast at each pumping session using a breast pump.
- Has a body mass index (BMI) of less than or equal to (<=) 36 kilograms per meter square (kg/m^2) and weighs at least 45 kilograms (kg) with all clinical assessments considered as clinically non-significant per investigator.
- Non-smoker (including vaping) or prior smokers (having smoked less than 10 cigarettes per day) who have stopped smoking for at least 1 month prior to screening.
- Understands the study procedures and is capable of providing written informed consent.
- A negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) will be required at Baseline before the dose of study intervention.
Exclusion Criteria:
- Participant is unwilling or unable to comply with the study restrictions or lifestyle guidelines presented in the protocol during the study period and through the post study visit.
- History or evidence of any clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric (including post-natal depression), neurologic, infectious, neoplastic, active cancer or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at time of dosing) or clinical findings that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant or infant by participation in the study.
- Has had major surgery in the past 3 months (except delivery through a C section and/or tubal ligation).
- History of significant multiple and/or severe allergies (including latex allergy, but with exception of seasonal rhinitis [hay fever]) or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food.
- Hypersensitivity to gepotidacin.
- Current or recent (less than [<] 14 days) mastitis, or history of breast surgery (augmentation or reduction).
- Use of any QT prolonging medications within 7 days prior to first dose, use of strong or moderate Cytochrome P450 3A4 (CYP3A4) inhibitors within 7 days prior to first dose, or use of strong or moderate CYP3A4 inducers (including vitamins, herbal and dietary supplements such as St. John's wort) within 14 days prior to first dose.
- Currently a user of illicit drugs or has a history of drug (including alcohol) abuse within approximately 1 year.
- Donated or lost 1 unit of blood (approximately 500 milliliters [mL]) or participated in another investigational study within 30 days or 5 half-lives of the investigational product prior to the screening. The 30 days window will be derived from the date of the last study procedure (i.e., poststudy, AE follow-up, etc.) in the previous study to the screening visit of the current study.
- The participant has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
- Participants with excessive caffeine intake (defined as greater than [>] 6 servings [1 serving is approximately equivalent to 120 milligram [mg] of caffeine] of coffee, tea, cola or other caffeinated beverages per day) within 14 days prior to first dose.
- The participant has known severe renal impairment (creatinine clearance <30 milliliters per minute [mL/min] or clinically significant elevated serum creatinine as determined by the investigator).
- The participant presents with (self-reported) vaginal discharge suspected for infection at Baseline.
- The participant has congenital long QT syndrome or known prolongation of the corrected QT (QTc) interval.
- The participant has a family history of QT prolongation or sudden death.
- The participant has a recent history of vasovagal syncope or episodes of symptomatic bradycardia or brady arrhythmia within the last 12 months.
- Having two or more of the following risk factors: 1. Body weight between 45 kg and 60 kg, 2. Moderate renal impairment (creatinine clearance 30 to 59 mL/min), 3. Moderate hepatic impairment (Child Pugh Class B)
- QTc >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.
- Severe hepatic impairment (Child Pugh Class C)
- Alanine aminotransferase >1.5*upper limit of normal (ULN).
- Total bilirubin >1.5*ULN; Participants with Gilbert's syndrome can be included with total bilirubin >1.5*ULN if direct bilirubin is <=1.5*ULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert's syndrome or asymptomatic gallstones).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Participants receiving Gepotidacin
|
A single oral dose of 3000 mg gepotidacin will be administered |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Area under the concentration-time curve from time zero to the last measurable concentration time point (t) (AUC[0 to t]) of gepotidacin in breast milk
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
AUC(0 to t) of gepotidacin in plasma
大体时间:Up to 48 hours post dose
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Up to 48 hours post dose
|
|
Maximum drug concentration (Cmax) of gepotidacin in plasma
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Area under the concentration-time curve from time zero to infinity (AUC[0 to infinity]) of gepotidacin in plasma
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
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AUC(0 to infinity) of gepotidacin in breast milk
大体时间:Up to 48 hours post dose
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Up to 48 hours post dose
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Cmax of gepotidacin in breast milk
大体时间:Up to 48 hours post dose
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Up to 48 hours post dose
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Concentration of gepotidacin in breast milk from time zero to the last measurable concentration time point (0 to t)
大体时间:Up to 48 hours post dose
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Up to 48 hours post dose
|
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Fraction of gepotidacin excreted in breast milk (0 to t) after a single dose administration
大体时间:Up to 48 hours post dose
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Up to 48 hours post dose
|
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Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
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Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Breast milk to Plasma ratio for Cmax of gepotidacin
大体时间:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Number of participants with adverse events (AEs) and serious adverse event (SAEs)
大体时间:Up to 14 days
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Up to 14 days
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 300585
- HSSO100201300011C (其他标识符:BARDA Agreement number)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
IPD 共享时间框架
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD 共享访问标准
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
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