Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: JTT-252 or Placebo
* Drug: JTT-252


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 2 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 3 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 4 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 5 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 6 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 7 JTT-252 or Placebo<br>Tablets, single dose in fasted condition | Drug: JTT-252 or Placebo<br>* Subjects will receive JTT-252 or Placebo<br>|
| Experimental: Dose 8 JTT-252<br>Tablets, single dose in fed condition | Drug: JTT-252<br>* Subjects will receive JTT-252<br>|
| Experimental: Dose 9 JTT-252<br>Tablets, single dose in fasted condition | Drug: JTT-252<br>* Subjects will receive JTT-252<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | 22 days | 
| Vital signs and 12 lead ECGs |  | 22 days | 
| Cmax (maximum concentration) |  | 22 days | 
| t1/2 (elimination half-life) |  | 22 days | 
| AUC (area under the concentration-time curve) |  | 22 days | 
| fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval) |  | 3 days | 
| Plasma glucose |  | 22 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerability, Safety, Pharmacokinetics, Food-effect, Diabetes