A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: AZD1656; Drug: Placebo

• Registration Number: NCT01221545
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-14
• Study First Posted: 2010-10-15
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A - AZD1656	AZD1656	AZD1656
B - Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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.	From screening until Follow up

Secondary Outcome Measures

Name	Time	Method
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	From pre-dose Day 1 to 48 hours after dose
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	Insuline secretion from Day -1 to 2.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Chula Vista, California, United States