Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
- Registration Number
- NCT02120976
- Lead Sponsor
- Akros Pharma Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose 3 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 6 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 2 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 7 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 9 JTT-252 JTT-252 Tablets, single dose in fasted condition Dose 1 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 4 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 5 JTT-252 or Placebo JTT-252 or Placebo Tablets, single dose in fasted condition Dose 8 JTT-252 JTT-252 Tablets, single dose in fed condition
- Primary Outcome Measures
Name Time Method Plasma glucose 22 days fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval) 3 days Vital signs and 12 lead ECGs 22 days AUC (area under the concentration-time curve) 22 days Number of subjects with adverse events 22 days Cmax (maximum concentration) 22 days t1/2 (elimination half-life) 22 days
- Secondary Outcome Measures
Name Time Method