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

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: Diabetes Mellitus
• Intervention / Treatment: Drug: JTT-252 or Placebo; Drug: JTT-252

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

9

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	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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.
• Investigators: Study Chair: Yuichiro Neki, Akros Pharma Inc.

Study record dates

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: Diabetes; Safety; Pharmacokinetics; Tolerability; Food-effect
• Other Study ID Numbers: AT252-U-14-001