Clinical trial NCT02120976: Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of JTT-252
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Safety
Tolerability
Pharmacokinetics
Food-effect
Diabetes
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 22 days
measure: Vital signs and 12 lead ECGs
timeFrame: 22 days
measure: Cmax (maximum concentration)
timeFrame: 22 days
measure: t1/2 (elimination half-life)
timeFrame: 22 days
measure: AUC (area under the concentration-time curve)
timeFrame: 22 days
measure: fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
timeFrame: 3 days
measure: Plasma glucose
timeFrame: 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Akros Pharma Inc.
name: Yuichiro Neki
role: STUDY_CHAIR
References: