- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02555449
A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects
The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it takes the body to get rid of it.
Information about any side effects that may occur will also be collected.
Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant.
This study is for research purposes only and is not intended to treat any medical condition.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53704
- Covance Clinical Research Unit Inc.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
- Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening
Exclusion Criteria:
- Have participated in a [¹⁴C]-study within the last 6 months prior to admission for this study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
- Have a history of constipation or have had acute constipation within 3 weeks prior to admission
- Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
- Exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: [¹⁴C]-LY3202626
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
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Administered as solution by mouth
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Prazo: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
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Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
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Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
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Urinary Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Prazo: Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered
|
Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)
Prazo: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the maximum observed concentration (Cmax).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
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Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to Infinity (AUC[0-∞])
Prazo: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
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Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])
Prazo: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
Plasma radioactivity pharmacokinetics were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]).
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met
|
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Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma
Prazo: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
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Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.
|
Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose
|
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Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity
Prazo: From Dosing Until Release Criteria Is Met
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The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity
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From Dosing Until Release Criteria Is Met
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 15566
- I7X-EW-LLCC (Outro identificador: Eli Lilly and Company)
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