- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01367262
Disposition of Carbon-14-Labeled LY2886721 ([^14C]-LY2886721) Following Oral Administration in Healthy Human Participants
9 de agosto de 2019 atualizado por: Eli Lilly and Company
Disposition of [14C]-LY2886721 Following Oral Administration in Healthy Human Subjects
This open-label study is being conducted to determine the metabolism and physiological disposition of radiolabeled LY2886721 after a single dose in healthy male participants.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
6
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.
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Macho
Descrição
Inclusion Criteria:
- Healthy males as determined by medical history and physical examination
- Males will be sterile (including vasectomy) or if the participant is not sterile and is sexually active, he will agree to use from check-in until 3 months after exit/discharge, 1 of the following approved methods of contraception: a male condom with spermicide, a sterile sexual partner, use by female sexual partner of an intrauterine device with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, intravaginal, or injectable contraceptives
- Have a body mass index of 19 to 30 kilograms per square meter (kg/m^2)
- Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
- Have venous access sufficient to allow for blood sampling
- Have normal blood pressure and heart rate (sitting)
- Experience a minimum of at least 1 bowel movement per day
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- Have given written informed consent approved by Lilly and the institutional review board (IRB) governing the site
Exclusion Criteria:
- Are currently enrolled in, have completed, or discontinued within the last 30 days from, a clinical trial involving an investigational product other than the investigational product used in this study; or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Have known allergies to LY2886721, related compounds, or any components of the formulation
- Are persons who have previously received the investigational product in this study, have completed or withdrawn from this study or any other study investigating LY2886721
- Have a Bazett's corrected QT (QTcB) interval value of >450 milliseconds (msec) or any abnormality in the 12-lead electrocardiogram (ECG) increases the risks associated with participating in the study
- Have an abnormal blood pressure
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- Intend to use prescription medication, over-the-counter medication, or herbal preparations containing St. John's Wort, kava, garlic, ginger, ginko biloba, or guarana within 14 days prior to admission
- Eating of grapefruit or grapefruit-containing foods, or drinking grapefruit-containing juices within 7 days prior to dosing or any time during the study
- Have used any tobacco- or nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to dosing
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65), or are unwilling to stop alcohol consumption from 48 hours prior to check-in until end of study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
- Show evidence of significant active neuropsychiatric disease, in particular evidence of significant medical or psychiatric illness within the past 12 months. Have any other condition that would preclude participation in the study
- Have a history or presence of epilepsy, a history of seizures, any known brain abnormalities, and a history of significant brain injury
- Have participated in a [^14C] study within the last 6 months prior to check-in for this study. The total exposure from this study and the previous study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1), less than 5,000 millirems (mrem)/year whole body annual exposure
- Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
- Have a history of clinically significant adverse drug reactions or "drug allergy" to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)
- Have a history of, or current, significant ophthalmological disease
- Have evidence of active renal disease (for example, diabetic renal disease, polycystic kidney disease) or creatinine clearance of <80 milliliters per minute (mL/min) as calculated by Cockcroft-Gault equation: Men: (140-age)*weight in kilograms (kg)/72*[serum creatinine in milligrams per deciliter (mg/dL)]
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: Outro
- 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: Radiolabeled LY2886721
Single 25 milligram (mg) oral dose containing 80 microCuries of radiolabeled LY2886721
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Administered orally
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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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Percentage of Urinary and Fecal Excretion of LY2886721 Radioactivity Over Time
Prazo: Predose up to 7 days (168 hours) postdose
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Urinary and fecal excretion of LY2886721 radioactivity over time was expressed as a percentage of the total radioactive dose administered.
The amount of drug-related material excreted in urine and feces (Ae) at a specific collection interval (i) was calculated as the product of radioactivity concentration and volume or weight.
The Ae values for each collection interval were then summed and calculated as Total Ae=Ae(i1)+Ae(i2)+Ae(in).
The percentage of the total radiolabeled dose administered that was excreted in feces or urine=[(Total Ae)/(Total radioactive dose administered)]*100.
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Predose up to 7 days (168 hours) postdose
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Plasma Pharmacokinetics (PK) of LY2886721: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0 to Inf)]
Prazo: Predose up to 4 days (96 hours) postdose
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Predose up to 4 days (96 hours) postdose
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PK of Radioactivity: AUC(0 to Inf)
Prazo: Predose up to 4 days (96 hours) postdose
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AUC(0 to inf) for plasma and whole blood total radioactivity is reported as hours*nanogram equivalents per milliliter (h*ng Eq/mL).
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Predose up to 4 days (96 hours) postdose
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Plasma PK of LY2886721: Maximum Observed Concentration (Cmax)
Prazo: Predose up to 4 days (96 hours) postdose
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Predose up to 4 days (96 hours) postdose
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PK of Radioactivity: Cmax
Prazo: Predose up to 4 days (96 hours) postdose
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The Cmax of total radioactivity in plasma and whole blood are reported as nanogram equivalents per milliliter (ng Eq/mL).
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Predose up to 4 days (96 hours) postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Plasma
Prazo: 1 to 8 hours postdose
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The metabolites of LY2886721 were identified using a high performance liquid chromatography (HPLC) chromatogram.
The relative abundance of LY2886721 and its metabolites in plasma were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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1 to 8 hours postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Urine
Prazo: 0 to 72 hours postdose
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The metabolites of LY2886721 were identified using an HPLC chromatogram.
The relative abundance of LY2886721 and its metabolites in urine were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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0 to 72 hours postdose
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Relative Abundance of LY2886721 and the Metabolites of LY2886721 in Feces
Prazo: 0 to 144 hours postdose
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The metabolites of LY2886721 were identified using an HPLC chromatogram.
The relative abundance of LY2886721 and its metabolites in feces were reported as a percentage of recovered radioactivity and calculated by dividing the sum of the radioactive content of fractions contributing to a particular peak by the sum of the radioactive content of all fractions in the radio chromatogram, then multiplying by 100.
Radioactivity corresponds to 80 μCi [^14C]-LY2886721.
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0 to 144 hours postdose
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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
1 de junho de 2011
Conclusão Primária (Real)
1 de julho de 2011
Conclusão do estudo (Real)
1 de julho de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
3 de junho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2011
Primeira postagem (Estimativa)
7 de junho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de setembro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de agosto de 2019
Última verificação
1 de maio de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 13736
- I4O-MC-BACD (Outro identificador: Eli Lilly and Company)
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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