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- Ensayo clínico NCT03590860
A Study of LY3322207 in Healthy Participants and in Participants With Hypertension (High Blood Pressure)
22 de febrero de 2019 actualizado 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
62
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Groningen, Países Bajos, 9728 NZ
- PRA Health Sciences
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: LY3322207 (Part A)
LY3322207 administered subcutaneously (SC)
|
Administered by SC injection
|
|
Comparador de placebos: Placebo (Part A)
Placebo matching LY3322207 administered SC
|
Administrado por inyección SC
|
|
Experimental: LY3322207 (Part B)
LY3322207 administered SC once weekly
|
Administered by SC injection
|
|
Comparador de placebos: Placebo (Part B)
Placebo matching LY3322207 administered SC once weekly
|
Administrado por inyección SC
|
|
Experimental: LY3322207 (Part C)
LY3322207 administered SC in participants with hypertension
|
Administered by SC injection
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants with One or More Serious Adverse Events (Part A)
Periodo de tiempo: Baseline up to approximately 31 days
|
Serious and other non-serious adverse events will be reported in the Adverse Events Module
|
Baseline up to approximately 31 days
|
|
Number of Participants with One or More Serious Adverse Events (Part B)
Periodo de tiempo: 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
|
|
Number of Participants with One or More Serious Adverse Events (Part C)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part A)
Periodo de tiempo: Predose up approximately 31 days
|
Pharmacokinetics (PK): AUC of LY3322207
|
Predose up approximately 31 days
|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part B)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
|
Predose up to approximately 9 weeks
|
|
Area Under the Concentration Versus Time Curve (AUC) of LY3322207 (Part C)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: AUC of LY3322207
|
Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part A)
Periodo de tiempo: Predose up approximately 31 days
|
PK: Cmax of LY3322207
|
Predose up approximately 31 days
|
|
Maximum Concentration (Cmax) of LY3322207 (Part B)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Maximum Concentration (Cmax) of LY3322207 (Part C)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: Cmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Time to reach Cmax (Tmax) of LY3322207 (Part A)
Periodo de tiempo: Predose up to approximately Day 31
|
PK: Tmax of LY3322207
|
Predose up to approximately Day 31
|
|
Time to reach Cmax (Tmax) of LY3322207 (Part B)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Time to reach Cmax (Tmax) of LY3322207 (Part C)
Periodo de tiempo: Predose up to approximately 9 weeks
|
PK: Tmax of LY3322207
|
Predose up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part A)
Periodo de tiempo: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part B)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Systolic Blood Pressure (SBP) (Part C)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part A)
Periodo de tiempo: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part B)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Diastolic Blood Pressure (DBP) (Part C)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part A)
Periodo de tiempo: Baseline up approximately 31 days
|
Supine position
|
Baseline up approximately 31 days
|
|
Change from Baseline in Heart Rate (Part B)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
|
Change from Baseline in Heart Rate (Part C)
Periodo de tiempo: Baseline up to approximately 9 weeks
|
Supine position
|
Baseline up to approximately 9 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
13 de julio de 2018
Finalización primaria (Actual)
17 de enero de 2019
Finalización del estudio (Actual)
17 de enero de 2019
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2018
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2018
Publicado por primera vez (Actual)
18 de julio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de febrero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
22 de febrero de 2019
Última verificación
1 de febrero de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16771
- I9K-MC-UCAA (Otro identificador: Eli Lilly and Company)
- 2018-002337-38 (Número EudraCT)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .