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

Phase 1

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: JTT-251 or Placebo

• Registration Number: NCT02106585
• Lead Sponsor: Akros Pharma Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 6 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 7 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 1 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 3 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 9 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition
Dose 2 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 5 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 8 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition
Dose 4 JTT-251 or Placebo	JTT-251 or Placebo	Tablets, single dose in fed condition

Primary Outcome Measures

Name	Time	Method
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)	1 week
Cmax (maximum concentration)	1 week
Vital signs and 12 lead ECGs	1 week
t1/2 (elimination half-life)	1 week
Number of subjects with adverse events	1 week
AUC (area under the concentration-time curve)	1 week