AZ8329: To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01207089

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight Healthy Male	Drug: AZD8329 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

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 Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 1	Drug: Placebo Placebo AZD8329 Oral Solution
Experimental: 2 AZD8329	Drug: AZD8329 AZD8329 Oral Solution 20mg/ml

Arm

Intervention/Treatment

Placebo Comparator: 1

Drug: Placebo

Placebo AZD8329 Oral Solution

Experimental: 2

AZD8329

Drug: AZD8329

AZD8329 Oral Solution 20mg/ml

Outcome Measures

Primary Outcome Measures

Safety variables (adverse events). [Adverse events day -1]
Safety variables (adverse events). [Adverse events will colletected entire study]
Safety variables (clinical laboratory assessments). [Clinical labs day 1]
Safety variables (clinical laboratory assessments). [Day 4]
Safety variables (clinical laboratory assessments). [Day 8]
Safety variables (clinical laboratory assessments). [Day 12]
Safety variables (clinical laboratory assessments). [Clinical labs at follow up]
Safety variables (adverse events) [Adverse events will colletected entire study]
Safety variables (vital signs) [vital signs every hour during day 1]
Safety variables (physical examination) [performed at screening]
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 1]
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 1]
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 screening]
Safety variables (safety 12-lead paper electrocardiograms (pECG)) [pECG at follow up]
Safety variables (clinical laboratory assessments). [clinical labs at screening]
Safety variables (clinical laboratory assessments). [clinical labs day -3]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	London		United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair: Dr. Jan Eriksson, AstraZeneca
Study Director: Dr. Mirjana Kujacic, AstraZeneca
Principal Investigator: Dr. James Ritter, Quintiles Drug Research Unit at Guy's Hospital