To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329

Phase 1

Completed

• Conditions: Overweight; Healthy; Male
• Interventions: Drug: Placebo; Drug: AZD8329

• Registration Number: NCT01207089
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8329 following multiple ascending dose administrations in in overweight to obese but otherwise healthy male subjects.

Detailed Description

A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of oral AZD8329 after Administration of Multiple Ascending Doses in Abdominally Obese but otherwise Healthy Male Subjects

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-09
• Last Update Posted: 2011-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

Inclusion Criteria

• Have a body mass index (BMI) between 27 and 35 kg/m2 and a waist circumference greater than or equal to 102cm.
• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male subjects aged =20 to =50 years with suitable veins for cannulation or repeated venepuncture

Exclusion Criteria

• History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	AZD8329	AZD8329

Primary Outcome Measures

Name	Time	Method
Safety variables (adverse events).	Adverse events will colletected entire study
Safety variables (clinical laboratory assessments).	clinical labs day -3
Safety variables (adverse events)	Adverse events will colletected entire study
Safety variables (vital signs)	Vital Signs every hr during day 12
Safety variables (physical examination)	Performed at follow up
Safety variables (telemetry)	telemetry for 24hr. post dose day 12
Safety variables (digital electrocardiograms (dECGs))	dECG during 5min, 13 times 24 hr after dose day 12
Safety variables (safety 12-lead paper electrocardiograms (pECG))	pECG at follow up

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters	Information will be collected during day -1, day 1, 2, 3 and 12
Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue	Information will be collected from the time of day -1 throuout the study
Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation	Information will be collected from day -1 to follow up
To assess the effect on insulin after multiple doses of AZD8329	Information will be collected from day -2 to follow up
To assess the effect on glucose after multiple doses of AZD8329	Information will be collected from day -2 to follow up
To assess the effect on lipid variables after multiple doses of AZD8329	Information will be collected from day -2 to follow up

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom