- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01176097
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
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
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PLACEBO_COMPARATOR: 6 - 8 cohorts
2 patients in each cohort will receive placebo
|
oral suspension, escalating single doses
oral suspension,single doses
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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
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Plasma glucose and serum insulin determined on Day -1 through Day 4
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2920C00001
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.
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