Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252

April 29, 2015 updated by: Akros Pharma Inc.

A Phase 1, Randomized, Single-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of Single Oral Doses of JTT-252 in Healthy Subjects (Part I); in Conjunction With an Open-label Study to Evaluate the Effect of Food on the PK of JTT-252 in Healthy Subjects (Part II); and an Open-label Study to Evaluate the Safety, Tolerability, PK and Pharmacodynamics (PD) of Single Oral Doses of JTT-252 in Type 2 Diabetic Subjects (Part III)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
    • Texas
      • Austin, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose 1 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 2 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 3 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 4 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 5 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 6 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 7 JTT-252 or Placebo
Tablets, single dose in fasted condition
Drug: JTT-252 or Placebo
Subjects will receive JTT-252 or Placebo
EXPERIMENTAL: Dose 8 JTT-252
Tablets, single dose in fed condition
Drug: JTT-252
Subjects will receive JTT-252
EXPERIMENTAL: Dose 9 JTT-252
Tablets, single dose in fasted condition
Drug: JTT-252
Subjects will receive JTT-252

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events
Time Frame: 22 days
22 days
Vital signs and 12 lead ECGs
Time Frame: 22 days
22 days
Cmax (maximum concentration)
Time Frame: 22 days
22 days
t1/2 (elimination half-life)
Time Frame: 22 days
22 days
AUC (area under the concentration-time curve)
Time Frame: 22 days
22 days
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
Time Frame: 3 days
3 days
Plasma glucose
Time Frame: 22 days
22 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akros Pharma Inc.

Investigators

  • Study Chair: Yuichiro Neki, Akros Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

April 21, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (ESTIMATE)

April 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AT252-U-14-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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