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

May 9, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety variables (adverse events).
Time Frame: Adverse events day -1
Adverse events day -1
Safety variables (adverse events).
Time Frame: Adverse events will colletected entire study
Adverse events will colletected entire study
Safety variables (clinical laboratory assessments).
Time Frame: Clinical labs day 1
Clinical labs day 1
Safety variables (clinical laboratory assessments).
Time Frame: Day 4
Day 4
Safety variables (clinical laboratory assessments).
Time Frame: Day 8
Day 8
Safety variables (clinical laboratory assessments).
Time Frame: Day 12
Day 12
Safety variables (clinical laboratory assessments).
Time Frame: Clinical labs at follow up
Clinical labs at follow up
Safety variables (adverse events)
Time Frame: Adverse events will colletected entire study
Adverse events will colletected entire study
Safety variables (vital signs)
Time Frame: vital signs every hour during day 1
vital signs every hour during day 1
Safety variables (physical examination)
Time Frame: performed at screening
performed at screening
Safety variables (vital signs)
Time Frame: Vital Signs every hr during day 12
Vital Signs every hr during day 12
Safety variables (physical examination)
Time Frame: Performed at follow up
Performed at follow up
Safety variables (telemetry)
Time Frame: telemetry for 24hr. post dose day 1
telemetry for 24hr. post dose day 1
Safety variables (telemetry)
Time Frame: telemetry for 24hr. post dose day 12
telemetry for 24hr. post dose day 12
Safety variables (digital electrocardiograms (dECGs))
Time Frame: dECG during 5min, 13 times 24 hr after dose day 1
dECG during 5min, 13 times 24 hr after dose day 1
Safety variables (digital electrocardiograms (dECGs))
Time Frame: dECG during 5min, 13 times 24 hr after dose day 12
dECG during 5min, 13 times 24 hr after dose day 12
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time Frame: pECG at screening
pECG at screening
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time Frame: pECG at follow up
pECG at follow up
Safety variables (clinical laboratory assessments).
Time Frame: clinical labs at screening
clinical labs at screening
Safety variables (clinical laboratory assessments).
Time Frame: clinical labs day -3
clinical labs day -3

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2350C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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