Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
NCT ID: NCT02120976
Last Updated: 2015-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
85 participants
INTERVENTIONAL
2014-04-30
2015-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dose 1 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 2 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 3 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 4 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 5 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 6 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 7 JTT-252 or Placebo
Tablets, single dose in fasted condition
JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
Dose 8 JTT-252
Tablets, single dose in fed condition
JTT-252
Subjects will receive JTT-252
Dose 9 JTT-252
Tablets, single dose in fasted condition
JTT-252
Subjects will receive JTT-252
Interventions
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JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
JTT-252
Subjects will receive JTT-252
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Yuichiro Neki
Role: STUDY_CHAIR
Akros Pharma Inc.
Locations
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Overland Park, Kansas, United States
Austin, Texas, United States
Countries
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Other Identifiers
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AT252-U-14-001
Identifier Type: -
Identifier Source: org_study_id
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