Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects

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 (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.

Official Title
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Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: JTT-251 or Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subject Cohorts: Healthy male or female subjects 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 diagnosed for at least 3 months BMI between 25 and 40 kg/m2 (inclusive) Have a glycosylated hemoglobin (HbA1c) of >6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR >6.5% to ≤10.0% (inclusive) if treated with metformin 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 >150 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 >160 mmHg and/or diastolic blood pressure >95 mmHg with documented ongoing treatment)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 2 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 3 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 4 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 5 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 6 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 7 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 8 JTT-251 or Placebo<br>Tablets, single dose in fed condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<br>|
| Experimental: Dose 9 JTT-251 or Placebo<br>Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition | Drug: JTT-251 or Placebo<br>* Subjects will receive JTT-251 or Placebo<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 |  | 1 week | 
| Vital signs and 12 lead ECGs |  | 1 week | 
| Cmax (maximum concentration) |  | 1 week | 
| t1/2 (elimination half-life) |  | 1 week | 
| AUC (area under the concentration-time curve) |  | 1 week | 
| fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval) |  | 1 week | 

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