NCT02106585

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P75+ for phase_1 diabetes-mellitus

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

April 4, 2014

Last Update Submit

October 3, 2014

Conditions

Diabetes Mellitus

Keywords

SafetyTolerabilityPharmacokineticsFood-effectDiabetes

Outcome Measures

Primary Outcomes (6)

  • Number of subjects with adverse events

    1 week

  • Vital signs and 12 lead ECGs

    1 week

  • Cmax (maximum concentration)

    1 week

  • t1/2 (elimination half-life)

    1 week

  • AUC (area under the concentration-time curve)

    1 week

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

    1 week

Study Arms (9)

Dose 1 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 2 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 3 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 4 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 5 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 6 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 7 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 8 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fed condition

Drug: JTT-251 or Placebo

Dose 9 JTT-251 or Placebo

EXPERIMENTAL

Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition

Drug: JTT-251 or Placebo

Interventions

JTT-251 or PlaceboDRUG

Subjects will receive JTT-251 or Placebo

Dose 1 JTT-251 or PlaceboDose 2 JTT-251 or PlaceboDose 3 JTT-251 or PlaceboDose 4 JTT-251 or PlaceboDose 5 JTT-251 or PlaceboDose 6 JTT-251 or PlaceboDose 7 JTT-251 or PlaceboDose 8 JTT-251 or PlaceboDose 9 JTT-251 or Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Orlando, Florida, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hideyuki Yamamoto

    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 4, 2014

First Posted

April 8, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

US(1)