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

Akros Pharma

Status and phase: Terminated; Phase 1

Conditions: Diabetes Mellitus

Treatments: Drug: JTT-252 or Placebo; Drug: JTT-252

Study type: Interventional

Funder types: Industry

Identifiers

NCT02120976

AT252-U-14-001

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

85 participants in 9 patient groups

Dose 1 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 2 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 3 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 4 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 5 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 6 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 7 JTT-252 or Placebo

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252 or Placebo

Dose 8 JTT-252

Experimental group

Description:

Tablets, single dose in fed condition

Treatment:

Drug: JTT-252

Dose 9 JTT-252

Experimental group

Description:

Tablets, single dose in fasted condition

Treatment:

Drug: JTT-252