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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02106585

Enrollment

Registered

2014-04-08

Start date

2014-03-31

Completion date

2014-08-31

Last updated

2014-10-07

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 (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.

Interventions

DRUGJTT-251 or Placebo

Subjects will receive JTT-251 or Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

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