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

February 1, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Chula Vista, California, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 6 - 8 cohorts
6 patients in each cohort will receive AZD5658
oral suspension, escalating single doses
oral suspension,single doses
PLACEBO_COMPARATOR: 6 - 8 cohorts
2 patients in each cohort will receive placebo
oral suspension, escalating single doses
oral suspension,single doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Pharmacodynamics (plasma glucose and serum insulin)
Time Frame: Plasma glucose and serum insulin determined on Day -1 through Day 4
Plasma glucose and serum insulin determined on Day -1 through Day 4
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Karin Wahlander, AstraZeneca R&DPepparedsleden 1431 83 M�lnda
  • Study Chair: Mirjana Kujacic, AstraZeneca R&DPepparedsleden 1431 83 M�lndal
  • Principal Investigator: Linda Morrow, Profil Institute for Clinical Research, Inc.855 Third Avenue, Suite 4400Chula Vista, CA 91911

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 1, 2011

Study Registration Dates

First Submitted

July 19, 2010

First Submitted That Met QC Criteria

August 4, 2010

First Posted (ESTIMATE)

August 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

3
Subscribe