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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01176097
First received: July 19, 2010
Last updated: February 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: AZD5658
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (plasma glucose and serum insulin) [ Time Frame: Plasma glucose and serum insulin determined on Day -1 through Day 4 ] [ Designated as safety issue: No ]
  • Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658. [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 6 - 8 cohorts
6 patients in each cohort will receive AZD5658
 Drug: AZD5658
oral suspension, escalating single doses
Placebo Comparator: 6 - 8 cohorts
2 patients in each cohort will receive placebo
 Drug: Placebo
oral suspension,single doses

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01176097

Locations
United States, California
Research Site
Chula Vista, California, United States
Sponsors and Collaborators
AstraZeneca
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01176097     History of Changes
Other Study ID Numbers: D2920C00001
Study First Received: July 19, 2010
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
First in man study evaluating AZD5658 in Type 2 Diabetics.
Effect of fasting
Safety
Tolerability

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013