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- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
22 de fevereiro de 2019 atualizado por: Eli Lilly and Company
A Safety, Tolerability, and Pharmacokinetic Study of Single and Multiple Ascending Doses of LY3322207 in Healthy Subjects and Subjects With Hypertension on ACE I/ARB Therapy
The purpose of this study is to investigate the safety of the study drug known as LY3322207.
Participants must be healthy or must have hypertension (high blood pressure).
Participants with hypertension may already be taking a common drug to reduce blood pressure called an angiotensin-converting enzyme inhibitor (ACE-I) or an angiotensin II receptor blocker (ARB).
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
62
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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Groningen, Holanda, 9728 NZ
- PRA Health Sciences
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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 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose
Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:
- Menopause: spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (for example: oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
- Surgical sterilization
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
- Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
- Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
- Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
- For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval
- Have previously completed or withdrawn from this study or any other study investigating this study drug
- Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, significant atopy, or any clinically significant laboratory abnormality that would preclude study participation
- Have abnormality in the 12-lead electrocardiogram (ECG) which increases study risk
- Have confirmed QT interval corrected by Bazett's method (QTcB) or Fridericia's (QTcF) method >450 millisecond (msec) for men and >470 msec for women
- Have prior Q-wave myocardial infarction or other, specific heart abnormalities, arrhythmias or fibrillations
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure greater than (>)95 or less than (<)50 millimeters of mercury (mmHg) and/or systolic blood pressure >160 or <90 mmHg
- Show evidence of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
- Have donated blood of more than 100 mL (milliliters) within the last month
- Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit
- Have an average weekly alcohol intake that exceeds 21 units per week (1 unit equal to (=) 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Have an abnormal blood pressure (supine) defined as diastolic blood pressure >95 or <50 mmHg and/or systolic blood pressure >160 or <90 mmHg
- Have serum potassium outside normal range
- Have had lymphoma, leukemia, or any malignancy within the past 5 years
- Have clinically significant multiple or severe drug allergies or intolerance
- Are lactating women
- Positive findings for known drugs of abuse
- Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
- Participation in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be compatible with this study
- Have estimated glomerular filtration rate (eGFR) < 60 milliliters per minute per 1.73 square meter (mL/min/1.73 m²) for Parts A and B of this study, or eGFR < 50 mL/min/1.73 m² in Part C only
- For Part C: have a history of severe hypertension (defined as SBP greater than or equal to (≥)180 mmHg and/or DBP ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension
- For Part C: have a history of supraventricular tachycardia (for example, atrial fibrillation), ventricular tachycardia, or other cardiac arrhythmia
- For Part C: have resting tachycardia (heart rate ≥100 beats per minute)
- For Part C: have New York Heart Association (NYHA) Class II, III, or IV heart failure, or had any of the following in the previous 3 months: coronary angioplasty, coronary stent placement, coronary bypass surgery or any significant cardiac surgery, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack
- For Part C: have an automatic internal cardioverter-defibrillator
- For Part C: have diabetes
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
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Administered by SC injection
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Comparador de Placebo: Placebo (Part A)
Placebo matching LY3322207 administered SC
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Administrado por injeção SC
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Experimental: LY3322207 (Part B)
LY3322207 administered SC once weekly
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Administered by SC injection
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Comparador de Placebo: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
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Administrado por injeção SC
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Experimental: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
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Administered by SC injection
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants with One or More Serious Adverse Events (Part A)
Prazo: Baseline up to approximately 31 days
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 31 days
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Number of Participants with One or More Serious Adverse Events (Part B)
Prazo: Baseline up to approximately 9 weeks
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Serious and other non-serious adverse events will be reported in the Adverse Events Module
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Baseline up to approximately 9 weeks
|
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Number of Participants with One or More Serious Adverse Events (Part C)
Prazo: Baseline up to approximately 9 weeks
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 9 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Prazo: Predose up approximately 31 days
|
Pharmacokinetics (PK): AUC of LY3322207
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Predose up approximately 31 days
|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Prazo: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
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Predose up to approximately 9 weeks
|
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Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
Prazo: Predose up to approximately 9 weeks
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PK: AUC of LY3322207
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Predose up to approximately 9 weeks
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Maximum Concentration (Cmax) of LY3322207 (Part A)
Prazo: Predose up approximately 31 days
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PK: Cmax of LY3322207
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Predose up approximately 31 days
|
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Maximum Concentration (Cmax) of LY3322207 (Part B)
Prazo: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Maximum Concentration (Cmax) of LY3322207 (Part C)
Prazo: Predose up to approximately 9 weeks
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PK: Cmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part A)
Prazo: Predose up to approximately Day 31
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PK: Tmax of LY3322207
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Predose up to approximately Day 31
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Time to reach Cmax (Tmax) of LY3322207 (Part B)
Prazo: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
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Time to reach Cmax (Tmax) of LY3322207 (Part C)
Prazo: Predose up to approximately 9 weeks
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PK: Tmax of LY3322207
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Predose up to approximately 9 weeks
|
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Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
Prazo: Baseline up approximately 31 days
|
Supine position
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Baseline up approximately 31 days
|
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Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Prazo: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
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Baseline up to approximately 9 weeks
|
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Change from Baseline in Heart Rate (Part A)
Prazo: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
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Change from Baseline in Heart Rate (Part B)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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Change from Baseline in Heart Rate (Part C)
Prazo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
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 (Real)
13 de julho de 2018
Conclusão Primária (Real)
17 de janeiro de 2019
Conclusão do estudo (Real)
17 de janeiro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
6 de julho de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de julho de 2018
Primeira postagem (Real)
18 de julho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de fevereiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de fevereiro de 2019
Última verificação
1 de fevereiro de 2019
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 16771
- I9K-MC-UCAA (Outro identificador: Eli Lilly and Company)
- 2018-002337-38 (Número EudraCT)
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
produto fabricado e exportado dos EUA
Sim
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 .