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

AstraZeneca1 site in 1 country45 target enrollmentApril 2010

ConditionsOverweight Obese

InterventionsAZD7687 Placebo

DrugsAZD7687 Placebo

Overview

Phase: Phase 1
Intervention: AZD7687
Conditions: Overweight
Sponsor: AstraZeneca
Enrollment: 45
Locations: 1
Primary Endpoint: Safety variables (adverse events, vital signs, physical examination, telemetry, digital electrocardiograms (dECGs), safety 12-lead paper electrocardiograms (pECG), and clinical laboratory assessments)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

March 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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

Arms & Interventions

1

Intervention: AZD7687

2

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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)