Study of Safety, Tolerability and Pharmacokinetics of Single Oral JTT-251 Doses in Healthy and Type 2 Diabetic Subjects

Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: JTT-251 or Placebo

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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 >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)

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-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 2 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 3 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 4 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 5 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 6 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 7 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: Dose 8 JTT-251 or Placebo; Tablets, single dose in fed condition	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo
EXPERIMENTAL: 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	Drug: JTT-251 or Placebo; Subjects will receive JTT-251 or Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): August 1, 2014

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 4, 2014
• First Posted (ESTIMATE): April 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 7, 2014
• Last Update Submitted That Met QC Criteria: October 3, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Diabetes; Safety; Pharmacokinetics; Tolerability; Food-effect
• Other Study ID Numbers: AT251-U-13-001