Clinical trial NCT01221545: A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Male, T2DM patients aged 20-60 years
* Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
* Patients should not have been treated with glitazones within 6 months prior to enrollment
* Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).

Exclusion Criteria:

* History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
* Prolonged QTcF\>450 msec or shortened QTcF\<350 msec or family history of long QT syndrome.
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
* Systolic BP\>159 mmHg or diastolic BP\>99 mmHg at screening and on Day-1

Primary outcomes:
measure: Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
timeFrame: From screening until Follow up
Secondary outcomes:
measure: Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656
timeFrame: From pre-dose Day 1 to 48 hours after dose
measure: Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
timeFrame: Glucose levels from Day -1 to day 3
measure: Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
timeFrame: Insuline secretion from Day -1 to 2.
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Profil Institute for Clinical Research, Inc.
name: Linda Morrow, MD
role: PRINCIPAL_INVESTIGATOR
References: