Suspended

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)

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What is being tested

JTT-252 or Placebo

+ JTT-252

Drug
Who is being recruted

Diabetes Mellitus+2

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2014
See protocol details

Summary

Principal SponsorAkros Pharma Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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.

Official TitleA 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)
NCT02120976
Principal SponsorAkros Pharma Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

85 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Tablets, single dose in fasted condition

Group II

Experimental
Tablets, single dose in fasted condition

Group III

Experimental
Tablets, single dose in fasted condition

Group IV

Experimental
Tablets, single dose in fasted condition

Group 5

Experimental
Tablets, single dose in fasted condition

Group 6

Experimental
Tablets, single dose in fasted condition

Group 7

Experimental
Tablets, single dose in fasted condition

Group 8

Experimental
Tablets, single dose in fed condition

Group 9

Experimental
Tablets, single dose in fasted condition

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers