Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
Completed · 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 (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.
Key facts
- Study ID
- NCT02106585
- Run by
- Akros Pharma Inc.
- People needed
- 94
- Starts
- 2014-03-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2014-10-07
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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 >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)
Where it is running
- Study site — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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