Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT02120976
- Run by
- Akros Pharma Inc.
- People needed
- 85
- Starts
- 2014-04-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-05-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Overland Park, Kansas, United States
- Study site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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