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

Primary Purpose

Overweight, Healthy, Male

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD8329
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overweight focused on measuring Safety, tolerability, PK, healthy, overweight, obese

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

AZD8329

Outcomes

Primary Outcome Measures

Safety variables (adverse events).
Safety variables (adverse events).
Safety variables (clinical laboratory assessments).
Safety variables (clinical laboratory assessments).
Safety variables (clinical laboratory assessments).
Safety variables (clinical laboratory assessments).
Safety variables (clinical laboratory assessments).
Safety variables (adverse events)
Safety variables (vital signs)
Safety variables (physical examination)
Safety variables (vital signs)
Safety variables (physical examination)
Safety variables (telemetry)
Safety variables (telemetry)
Safety variables (digital electrocardiograms (dECGs))
Safety variables (digital electrocardiograms (dECGs))
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Safety variables (clinical laboratory assessments).
Safety variables (clinical laboratory assessments).

Secondary Outcome Measures

Pharmacokinetics Plasma and urine concentrations of AZD8329 and plasma and urine pharmacokinetics parameters
Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue
Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation
To assess the effect on insulin after multiple doses of AZD8329
To assess the effect on glucose after multiple doses of AZD8329
To assess the effect on lipid variables after multiple doses of AZD8329

Full Information

First Posted
September 14, 2010
Last Updated
May 9, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01207089
Brief Title
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329
Acronym
AZ8329
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Healthy, Male
Keywords
Safety, tolerability, PK, healthy, overweight, obese

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Arm Description
AZD8329
Intervention Type
Drug
Intervention Name(s)
AZD8329
Intervention Description
AZD8329 Oral Solution 20mg/ml
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo AZD8329 Oral Solution
Primary Outcome Measure Information:
Title
Safety variables (adverse events).
Time Frame
Adverse events day -1
Title
Safety variables (adverse events).
Time Frame
Adverse events will colletected entire study
Title
Safety variables (clinical laboratory assessments).
Time Frame
Clinical labs day 1
Title
Safety variables (clinical laboratory assessments).
Time Frame
Day 4
Title
Safety variables (clinical laboratory assessments).
Time Frame
Day 8
Title
Safety variables (clinical laboratory assessments).
Time Frame
Day 12
Title
Safety variables (clinical laboratory assessments).
Time Frame
Clinical labs at follow up
Title
Safety variables (adverse events)
Time Frame
Adverse events will colletected entire study
Title
Safety variables (vital signs)
Time Frame
vital signs every hour during day 1
Title
Safety variables (physical examination)
Time Frame
performed at screening
Title
Safety variables (vital signs)
Time Frame
Vital Signs every hr during day 12
Title
Safety variables (physical examination)
Time Frame
Performed at follow up
Title
Safety variables (telemetry)
Time Frame
telemetry for 24hr. post dose day 1
Title
Safety variables (telemetry)
Time Frame
telemetry for 24hr. post dose day 12
Title
Safety variables (digital electrocardiograms (dECGs))
Time Frame
dECG during 5min, 13 times 24 hr after dose day 1
Title
Safety variables (digital electrocardiograms (dECGs))
Time Frame
dECG during 5min, 13 times 24 hr after dose day 12
Title
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time Frame
pECG at screening
Title
Safety variables (safety 12-lead paper electrocardiograms (pECG))
Time Frame
pECG at follow up
Title
Safety variables (clinical laboratory assessments).
Time Frame
clinical labs at screening
Title
Safety variables (clinical laboratory assessments).
Time Frame
clinical labs day -3
Secondary Outcome Measure Information:
Title
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
Title
Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue
Time Frame
Information will be collected from the time of day -1 throuout the study
Title
Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation
Time Frame
Information will be collected from day -1 to follow up
Title
To assess the effect on insulin after multiple doses of AZD8329
Time Frame
Information will be collected from day -2 to follow up
Title
To assess the effect on glucose after multiple doses of AZD8329
Time Frame
Information will be collected from day -2 to follow up
Title
To assess the effect on lipid variables after multiple doses of AZD8329
Time Frame
Information will be collected from day -2 to follow up

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jan Eriksson
Organizational Affiliation
AstraZeneca
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Mirjana Kujacic
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr. James Ritter
Organizational Affiliation
Quintiles Drug Research Unit at Guy's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26218540
Citation
Morentin Gutierrez P, Gyte A, deSchoolmeester J, Ceuppens P, Swales J, Stacey C, Eriksson JW, Sjostrand M, Nilsson C, Leighton B. Continuous inhibition of 11beta-hydroxysteroid dehydrogenase type I in adipose tissue leads to tachyphylaxis in humans and rats but not in mice. Br J Pharmacol. 2015 Oct;172(20):4806-16. doi: 10.1111/bph.13251. Epub 2015 Oct 8.
Results Reference
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To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Administration of AZD8329

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