AZD7687 Multiple Ascending Dose Study
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
2 other identifiers
interventional
45
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJanuary 19, 2012
January 1, 2012
11 months
May 6, 2010
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
Before, during and after dosing.
Secondary Outcomes (3)
Pharmacokinetics: Plasma and urine concentrations of AZD7687 and plasma and urine pharmacokinetic parameters
Information will be collected from the time of day -2 throughout the study.
Pharmacodynamic Biomarker sampling: (Triacylglycerol in serum, triacylglycerol, diacylglycerol, insulin and free fatty acids in plasma. Triacylglycerol and diacylglycerol in adipose tissue)
Information will be collected from the time of day -2 throughout the study.
Genetic: Blood sampling at one occasion during the study.
Once during study
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jan Eriksson
AstraZeneca
- STUDY CHAIR
Mirjana Kucajcic
AstraZeneca
- PRINCIPAL INVESTIGATOR
Darren Wilbraham
Quintiles, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 7, 2010
Study Start
April 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
January 19, 2012
Record last verified: 2012-01