Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients

This study has been terminated.
(Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00886366
First received: April 17, 2009
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.


Condition Intervention Phase
Type 2 Diabetes
Drug: AZD6714
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 Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) [ Time Frame: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic variables [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions. ] [ Designated as safety issue: No ]
  • Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide) [ Time Frame: Blood samples taken repeatedly during 24 hours on study day sessions. ] [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group)
Drug: AZD6714
Oral single doses a-h suspension
Drug: Placebo
Oral single doses suspension
Experimental: 2
2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food
Drug: Placebo
Oral single doses suspension
Drug: AZD6714
Oral single doses d and g suspension
Experimental: 3
Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients.
Drug: Placebo
Oral single doses suspension
Drug: AZD6714
Oral single doses a-d suspension

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
  • Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment

Exclusion Criteria:

  • Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
  • Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
  • Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.
  • Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
  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: NCT00886366

Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Klas Malmberg, MD, PhD AstraZeneca R&D Mölndal
Principal Investigator: Marianne Hartford CPU Sahlgrenska University Hospital
  More Information

No publications provided

Responsible Party: Klas Malmberg, MD, PhD, Prof. Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00886366     History of Changes
Other Study ID Numbers: D1920C00001
Study First Received: April 17, 2009
Last Updated: December 6, 2010
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:
Type II Diabetes

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

ClinicalTrials.gov processed this record on October 23, 2014