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A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Women

8 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

8

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Participants receiving Gepotidacin
A single oral dose of 3000 mg gepotidacin will be administered

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
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
Prazo: Up to 48 hours post dose
Up to 48 hours post dose

Medidas de resultados secundários

Medida de resultado
Prazo
AUC(0 to t) of gepotidacin in plasma
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Maximum drug concentration (Cmax) of gepotidacin in plasma
Prazo: 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
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
AUC(0 to infinity) of gepotidacin in breast milk
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Cmax of gepotidacin in breast milk
Prazo: 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)
Prazo: 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
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to t) of gepotidacin
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Breast milk to Plasma ratio for AUC (0 to infinity) of gepotidacin
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Breast milk to Plasma ratio for Cmax of gepotidacin
Prazo: Up to 48 hours post dose
Up to 48 hours post dose
Number of participants with adverse events (AEs) and serious adverse event (SAEs)
Prazo: Up to 14 days
Up to 14 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

9 de julho de 2026

Conclusão Primária (Estimado)

5 de maio de 2027

Conclusão do estudo (Estimado)

13 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de junho de 2026

Primeira postagem (Real)

12 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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