- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01354496
A Study of LY2409021 Formulations and the Effect of Food
LY2409021 Formulation Bridging and Food Effect Study
The purposes of this study are to compare how much of LY2409021 enters the bloodstream and how long the body takes to get rid of the drug when different formulations of LY2409021 are given, and when LY2409021 is taken with or without food.
The study will be conducted in 2 cohorts. Each cohort will have 3 study periods consisting of 3 formulations of LY2409021. Participants in each cohort will receive the same all 3 formulations using a randomized sequence crossover design. There is a washout period of at least 14 days between dosing periods.
There will be an interim analysis after Cohort 1 completes study Period 2. Cohort 2 will not begin enrolling until this analysis is complete. The need to enroll Cohort 2 will be determined by the outcome of the interim analysis.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur
- 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 person physician.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must be healthy male or a healthy female who cannot become pregnant
- Must have body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²), inclusive
- Blood pressure as well as blood and urine laboratory test results must be acceptable for the study
- The veins must be suitable for easy blood collection
- Must be willing to be available for the whole study and be willing to follow study procedures
Exclusion Criteria:
- Were in another new drug or medical research study in the last 30 days
- Have previously taken part in this study or any other study with LY2409021
- Have taken LY2409021, or drugs similar to LY2409021 before and was found to be allergic to the drug
- Currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study
- Electrocardiogram (ECG) readings are not suitable for the study
- Are infected with hepatitis B
- Are infected with human immunodeficiency disease virus (HIV)
- Are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study
- Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit
- Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
- Have a history of drug or alcohol abuse
- Have donated 450 milliliters (mL) or more of blood in the last 3 months
- Are unwilling or unable to comply with dietary requirements/restrictions during the study
- The study doctor thinks the participant should not participate for any other reasons
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Cohort 1 - LY2409021 reference form
A 20 milligram (mg) LY2409021 dose, reference form administered orally in the fasted state
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Administered orally
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Experimental: Cohort 1 - LY2409021 medium test form fed
Single 20 mg LY2409021 test form with medium particle size administered orally immediately after ingestion of a standardized high-fat meal
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Administered orally
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Experimental: Cohort 1 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
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Administered orally
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Experimental: Cohort 2 - LY2409021 low test form fasted
Single 20 mg LY2409021 test form with low particle size administered orally in the fasted state
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Administered orally
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Experimental: Cohort 2 - LY2409021 medium test form fasted
Single 20 mg LY2409021 test form with medium particle size administered orally in the fasted state
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Administered orally
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Experimental: Cohort 2 - LY2409021 high test form fasted
Single 20 mg LY2409021 test form with high particle size administered orally in the fasted state
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Administered orally
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Medium Test Form to Reference Form
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Maximum Concentration (Cmax): Medium Test Form to Reference Form
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Standardized High Fat Meal to Fasting
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Maximum Concentration (Cmax): Standardized High Fat Meal to Fasting
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Time to Maximum Concentration (Tmax)
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Area Under the Concentration-Time Curve (AUC): Low and High Particle Size to Medium Particle Size
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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AUC from time 0 to infinity (AUC0-∞).
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Pharmacokinetics, Concentration Maximum (Cmax): Low and High Particle Size to Medium Particle Size
Periodo de tiempo: Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Periods 1, 2, 3 (predose, 0.5, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, 144, 192, 240, 288, and 336 hours postdose)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 14194
- I1R-FW-GLBQ (Otro identificador: Eli Lilly and Company)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .
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