Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects
NCT ID: NCT02106585
Last Updated: 2014-10-07
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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COMPLETED
PHASE1
94 participants
INTERVENTIONAL
2014-03-31
2014-08-31
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-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 2 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 3 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 4 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 5 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 6 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 7 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 8 JTT-251 or Placebo
Tablets, single dose in fed condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Dose 9 JTT-251 or Placebo
Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition
JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Interventions
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JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
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 \>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)
18 Years
70 Years
ALL
Yes
Sponsors
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Akros Pharma Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hideyuki Yamamoto
Role: STUDY_CHAIR
Akros Pharma Inc.
Locations
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Orlando, Florida, United States
Countries
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Other Identifiers
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AT251-U-13-001
Identifier Type: -
Identifier Source: org_study_id
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