NCT02120976

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 1, 2015

Status Verified

April 1, 2015

Enrollment Period

10 months

First QC Date

April 21, 2014

Last Update Submit

April 29, 2015

Conditions

Diabetes Mellitus

Keywords

SafetyTolerabilityPharmacokineticsFood-effectDiabetes

Outcome Measures

Primary Outcomes (7)

  • Number of subjects with adverse events

    22 days

  • Vital signs and 12 lead ECGs

    22 days

  • Cmax (maximum concentration)

    22 days

  • t1/2 (elimination half-life)

    22 days

  • AUC (area under the concentration-time curve)

    22 days

  • fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)

    3 days

  • Plasma glucose

    22 days

Study Arms (9)

Dose 1 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 2 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 3 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 4 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 5 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 6 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 7 JTT-252 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252 or Placebo

Dose 8 JTT-252

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-252

Dose 9 JTT-252

EXPERIMENTAL

Tablets, single dose in fasted condition

Drug: JTT-252

Interventions

JTT-252 or PlaceboDRUG

Subjects will receive JTT-252 or Placebo

Dose 1 JTT-252 or PlaceboDose 2 JTT-252 or PlaceboDose 3 JTT-252 or PlaceboDose 4 JTT-252 or PlaceboDose 5 JTT-252 or PlaceboDose 6 JTT-252 or PlaceboDose 7 JTT-252 or Placebo
JTT-252DRUG

Subjects will receive JTT-252

Dose 8 JTT-252Dose 9 JTT-252

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Austin, Texas, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Yuichiro Neki

    Akros Pharma Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2014

First Posted

April 23, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

May 1, 2015

Record last verified: 2015-04

Locations

US(2)