A Phase 1, Randomized, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single Oral Doses of JTT-252 in Healthy Subjects (Part I); in Conjunction With an Open-label Study to Evaluate the Effect of Food on the PK of JTT-252 in Healthy Subjects (Part II); and an Open-label Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics (PD) of Single Oral Doses of JTT-252 in Type 2 Diabetic Subjects (Part III)
JTT-252 or Placebo
+ JTT-252
Enfermedades del Sistema Endocrino+1
+ Diabetes Mellitus
+ Enfermedades metabólicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 2014
Fecha en la que se inscribió al primer participante.The purpose of this study is to evaluate the safety, tolerability, and PK of single oral doses of JTT-252 and the effect of food on the PK of JTT-252 in healthy subjects, and to evaluate the safety, tolerability, PK and PD of single oral doses of JTT-252 in type 2 diabetes mellitus subjects.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 85 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 65 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Healthy Subject Cohorts: * Healthy male or female subjects * Age 18 to 50 Years (inclusive) * Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive) Type 2 Diabetic Subject Cohorts: * Male or female Type 2 diabetic subjects who are currently being treated with a stable dose of metformin * Age 18 to 65 Years (inclusive) * BMI between 25.0 and 40.0 kg/m2 (inclusive) * Have a glycosylated hemoglobin (HbA1c) of \>7.0% to ≤9.5% * Have a fasting plasma glucose (FPG) \<240 mg/dL Exclusion Criteria: Healthy Subject Cohorts: * Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic and dermatological or connective tissue disease * Subjects with a systolic blood pressure \>140 mmHg and/or diastolic blood pressure \>90 mmHg Type 2 Diabetic Subject Cohorts: * Subjects with a known medical history or presence of type 1 diabetes mellitus * Subjects with known medical history of acute metabolic diabetic complications * Subjects with uncontrolled hypertension (systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.9 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalGrupo III
ExperimentalGrupo IV
ExperimentalGrupo 5
ExperimentalGrupo 6
ExperimentalGrupo 7
ExperimentalGrupo 8
ExperimentalGrupo 9
ExperimentalObjetivos del Estudio
Objetivos Primarios