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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014