AZD7687 Multiple Ascending Dose Study
- Registration Number
- NCT01119352
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 AZD7687 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom