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
Diabetes Mellitus+2
+ Endocrine System Diseases
+ Metabolic Diseases
Treatment Study
Summary
Study start date: April 1, 2014
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.85 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.9 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
ExperimentalStudy Objectives
Primary Objectives