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

Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106585
• Other study ID #: AT251-U-13-001
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2014
• Last updated: October 3, 2014
• Start date: March 2014
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Akros Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• JTT-251 or Placebo
Subjects will receive JTT-251 or Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akros Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		1 week	Yes
Primary	Vital signs and 12 lead ECGs		1 week	Yes
Primary	Cmax (maximum concentration)		1 week	No
Primary	t1/2 (elimination half-life)		1 week	No
Primary	AUC (area under the concentration-time curve)		1 week	No
Primary	fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)		1 week	No