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

Diabetes Mellitus Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02120976
• Other study ID #: AT252-U-14-001
• Status: Terminated
• Phase: Phase 1
• First received: April 21, 2014
• Last updated: April 29, 2015
• Start date: April 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 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-252 or Placebo
Subjects will receive JTT-252 or Placebo
• JTT-252
Subjects will receive JTT-252

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		22 days	Yes
Primary	Vital signs and 12 lead ECGs		22 days	Yes
Primary	Cmax (maximum concentration)		22 days	No
Primary	t1/2 (elimination half-life)		22 days	No
Primary	AUC (area under the concentration-time curve)		22 days	No
Primary	fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)		3 days	No
Primary	Plasma glucose		22 days	No