A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women
2026年6月8日 更新者:GlaxoSmithKline
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.
調査の概要
研究の種類
介入
入学 (推定)
8
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:US GSK Clinical Trials Call Center
- 電話番号:877-379-3718
- メール:GSKClinicalSupportHD@gsk.com
研究連絡先のバックアップ
- 名前:EU GSK Clinical Trials Call Center
- 電話番号:+44 (0) 20 89904466
- メール:GSKClinicalSupportHD@gsk.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Participants receiving Gepotidacin
|
A single oral dose of 3000 mg gepotidacin will be administered
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
AUC(0 to t) of gepotidacin in plasma
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Maximum drug concentration (Cmax) of gepotidacin in plasma
時間枠: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
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
AUC(0 to infinity) of gepotidacin in breast milk
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Cmax of gepotidacin in breast milk
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Concentration of gepotidacin in breast milk from time zero to the last measurable concentration time point (0 to t)
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Fraction of gepotidacin excreted in breast milk (0 to t) after a single dose administration
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Breast milk to Plasma ratio for Cmax of gepotidacin
時間枠:Up to 48 hours post dose
|
Up to 48 hours post dose
|
|
Number of participants with adverse events (AEs) and serious adverse event (SAEs)
時間枠:Up to 14 days
|
Up to 14 days
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月9日
一次修了 (推定)
2027年5月5日
研究の完了 (推定)
2027年5月13日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月12日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 300585
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
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