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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: AZD1656; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01221545

D1020C00044

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: Male

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

24 participants in 2 patient groups, including a placebo group

A - AZD1656

Experimental group

Description:

AZD1656

Treatment:

Drug: AZD1656

B - Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo