- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01387087
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33014
- Clinical Pharmacology of Miami
-
-
Minnesota
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St. Paul, Minnesota, Estados Unidos, 55114
- Prism Research
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- If female, the subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
- If male, the subject agrees to sexual abstinence and/or to use a highly effective method of birth control during the study period
- Subject is medically healthy, with no clinically significant abnormalities on medical history or abnormalities observed upon physical examination or 12 lead electrocardiogram (ECG)
- Subject's fasting clinical laboratory values are within normal limits
- Subject is a non-smoker and has not used tobacco for a minimum of 3 months
- Subjects must weigh at least 45 kg and have a Body Mass Index (BMI) of 18-32 kg/m2
Exclusion Criteria:
- Subject has a positive test for hepatitis C antibody, or positive for hepatitis B surface antigen (HBsAg)
- Subject has a history of the human immunodeficiency virus (HIV) antibody
- Subject has a history of severe allergic or anaphylactic reactions
- Subject has a history of chronic diarrhea
- Subject has been vaccinated within the last 60 days prior to study drug administration
- Subject has a previous history of any clinically significant neurological, gastrointestinal, renal, hepatic, pulmonary, metabolic, cardiovascular, psychiatric, endocrine, hematological disorder or disease, or any other medical condition that, in the Investigator's opinion, would preclude participation in the study
- Subject has had clinically significant illness within 1 month prior to study drug administration
- Subject has a history of hemorrhoids
- Subject has a history of drug or alcohol abuse or a positive urine screen for alcohol or drugs of abuse and/or illegal drugs
- Subject has had treatment with prescription medication (except hormone replacement therapy and acetaminophen), complementary and alternative medicines (CAM) within 14 days, over-the-counter products within 1 week, or alcohol, caffeine or grapefruit juice within 24 hours prior to study drug administration
- Subject has had treatment with another investigational drug or approved therapy for investigational use within 30 days or 10 half-lives, whichever is longer, prior to study drug administration or has participated in a prior group in the current study
- Subject has a history of blood donation within 30 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A
Lowest dose, all males, fasting
|
oral
|
|
Experimental: Group B
Second lowest dose, all males, fasting
|
oral
|
|
Experimental: Group C
Third lowest dose, all males, fasting
|
oral
|
|
Experimental: Group D
Middle dose, all males, fasting
|
oral
|
|
Experimental: Group E
Third lowest dose, all females, fasting
|
oral
|
|
Experimental: Group F
Third highest dose, all males, fasting then fed
|
oral
|
|
Experimental: Group G
Second highest dose, all males, fasting
|
oral
|
|
Experimental: Group H
Highest dose, all males, fasting
|
oral
|
|
Experimental: Group I
Second highest dose, all females, fasting
|
oral
|
|
Comparador de placebos: Placebo Group A
all male, fasting
|
oral
|
|
Comparador de placebos: Placebo Group B
all male, fasting then fed
|
oral
|
|
Comparador de placebos: Placebo Group C
all female, fasting
|
oral
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples
Periodo de tiempo: 8 days
|
8 days
|
|
Pharmacokinetic assessment through the analysis of blood and urine samples
Periodo de tiempo: Up to Day 4
|
Up to Day 4
|
|
Pharmacodynamic assessment through the analysis of blood samples
Periodo de tiempo: Up to Day 4
|
Up to Day 4
|
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 015K-CL-HV01
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. .