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

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)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02120976

Enrollment

Registered

2014-04-23

Start date

2014-04-30

Completion date

2015-03-31

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Safety, Tolerability, Pharmacokinetics, Food-effect, Diabetes

Brief 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.

Interventions

DRUGJTT-252 or Placebo

Subjects will receive JTT-252 or Placebo

DRUGJTT-252

Subjects will receive JTT-252

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of subjects with adverse events	22 days
Vital signs and 12 lead ECGs	22 days
Cmax (maximum concentration)	22 days
t1/2 (elimination half-life)	22 days
AUC (area under the concentration-time curve)	22 days
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)	3 days
Plasma glucose	22 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026