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Completed

NCT Number: NCT01176097

To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes

The purpose of this study is to investigate the safety and tolerability of AZD5658 following ascending single oral doses in Type 2 Diabetics. It will also estimate the maximum tolerated dose.

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Key information

Conditions

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

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Chula Vista, California, United States

About this study

This is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of AZD5658 in type 2 diabetes mellitus patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must be of non-childbearing potential.
  • Body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2
  • Patients with confirmed Type 2 Diabetes diagnosis for at least 1 year and treated with Metformin

Exclusion criteria

  • Clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the IP
  • Participation in another clinical study during the last 30 days prior to enrollment
  • Significant cardiovascular event within the last 6 months prior to enrollment

Treatment and study plan

AZD5658

Drug

oral suspension, escalating single doses

Placebo

Drug

oral suspension,single doses

Primary outcomes

  1. To investigate the safety and tolerability of AZD5658 following oral administration of single ascending doses and to estimate the maximum tolerated dose (MTD).

    Time frame: AEs-, blood pressure and pulse during study days. Safety labs - day -1 to day 4; ECG - days 1, 2 and 3

Secondary outcomes

  1. To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.

    Time frame: Venous blood samples for the determination of concentrations of AZD5658 in plasma will be taken predose and at various times up to 72 hours postdose

  2. Pharmacodynamics (plasma glucose and serum insulin)

    Time frame: Plasma glucose and serum insulin determined on Day -1 through Day 4

  3. Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Single-Blind, Placebo-Controlled, Single-Center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and the Effect of Fasting After Single Ascending Oral Doses of AZD5658 in Type 2 Diabetes Mellitus Patients

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 5, 2010
Registry last updated
Feb 2, 2012

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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