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Completed

NCT Number: NCT01221545

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1656

Drug

3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.

Placebo

Drug

Placebo

Primary outcomes

  1. 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.

    Time frame: From screening until Follow up

Secondary outcomes

  1. 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

    Time frame: From pre-dose Day 1 to 48 hours after dose

  2. 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

    Time frame: Glucose levels from Day -1 to day 3

  3. 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

    Time frame: Insuline secretion from Day -1 to 2.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 15, 2010
Registry last updated
Feb 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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