Back to resultsTo Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD5658
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring First in man study evaluating AZD5658 in Type 2 Diabetics., Effect of fasting, Safety, Tolerability
Eligibility 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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
6 - 8 cohorts
6 - 8 cohorts
Arm Description
6 patients in each cohort will receive AZD5658
2 patients in each cohort will receive placebo
Outcomes
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).
Secondary Outcome Measures
To investigate the pharmacokinetics of AZD5658 after single ascending oral doses in type 2 diabetes mellitus patients.
Pharmacodynamics (plasma glucose and serum insulin)
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01176097
Brief Title
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
First in man study evaluating AZD5658 in Type 2 Diabetics., Effect of fasting, Safety, Tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 - 8 cohorts
Arm Type
Experimental
Arm Description
6 patients in each cohort will receive AZD5658
Arm Title
6 - 8 cohorts
Arm Type
Placebo Comparator
Arm Description
2 patients in each cohort will receive placebo
Intervention Type
Drug
Intervention Name(s)
AZD5658
Intervention Description
oral suspension, escalating single doses
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral suspension,single doses
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Pharmacodynamics (plasma glucose and serum insulin)
Time Frame
Plasma glucose and serum insulin determined on Day -1 through Day 4
Title
Effect of fasting on the pharmacokinetics and explore the pharmacodynamics of AZD5658.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Wahlander
Organizational Affiliation
AstraZeneca R&DPepparedsleden 1431 83 M�lnda
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mirjana Kujacic
Organizational Affiliation
AstraZeneca R&DPepparedsleden 1431 83 M�lndal
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Linda Morrow
Organizational Affiliation
Profil Institute for Clinical Research, Inc.855 Third Avenue, Suite 4400Chula Vista, CA 91911
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Chula Vista
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Assess Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and the Effect of Fasting After Single Oral Doses of AZD5658 in Type 2 Diabetes
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