Back to resultsAZD7687 Multiple Ascending Dose Study
Primary Purpose
Overweight, Obese
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD7687
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Overweight focused on measuring Safety, tolerability, PK, healthy, overweight, obese
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures
- suitable veins for cannulation or repeated venepuncture.
- Have a body mass index (BMI) between 27 and 35 kg/m2
Exclusion Criteria:
- Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening.
- Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.
- Smoking more than 7 cigarettes per week from time of consent
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
Secondary Outcome Measures
Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters
Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)
Genetic: Blood sampling at one occasion during the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119352
Brief Title
AZD7687 Multiple Ascending Dose Study
Official Title
A Phase 1, Single Centre, Single-Blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD7687 After Administration of Multiple Ascending Doses in Overweight to Obese But Otherwise Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD7687 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese
Keywords
Safety, tolerability, PK, healthy, overweight, obese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD7687
Intervention Description
Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral suspension, once daily. Totally 8 doses
Primary Outcome Measure Information:
Title
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
Time Frame
Before, during and after dosing.
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters
Time Frame
Information will be collected from the time of day -2 throughout the study.
Title
Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)
Time Frame
Information will be collected from the time of day -2 throughout the study.
Title
Genetic: Blood sampling at one occasion during the study.
Time Frame
Once during study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated, written informed consent prior to any study specific procedures
suitable veins for cannulation or repeated venepuncture.
Have a body mass index (BMI) between 27 and 35 kg/m2
Exclusion Criteria:
Fasting serum (S)-glucose ≥7.0 mmol/L or non-fasting S-glucose ≥11.1 mmol/L at screening.
Any eating disorder or actively attempting to loose weight within 3 months prior to enrolment.
Smoking more than 7 cigarettes per week from time of consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Eriksson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mirjana Kucajcic
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Darren Wilbraham
Organizational Affiliation
Quintiles, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
AZD7687 Multiple Ascending Dose Study
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