Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/13/2015 |
| Start Date: | April 2014 |
| End Date: | April 2015 |
| Contact: | Hideyuki Yamamoto |
| Email: | yamamotoh@akrospharma.com |
| Phone: | 609-919-6111 |
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)
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.
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.
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
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