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

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207089
• Other study ID #: D2350C00010
• Status: Completed
• Phase: Phase 1
• First received: September 14, 2010
• Last updated: May 9, 2011
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Male
• Overweight

Intervention

Drug:
• AZD8329
AZD8329 Oral Solution 20mg/ml
• Placebo
Placebo AZD8329 Oral Solution

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (adverse events).		Adverse events day -1	Yes
Primary	Safety variables (adverse events).		Adverse events will colletected entire study	Yes
Primary	Safety variables (clinical laboratory assessments).		Clinical labs day 1	Yes
Primary	Safety variables (clinical laboratory assessments).		Day 4	Yes
Primary	Safety variables (clinical laboratory assessments).		Day 8	Yes
Primary	Safety variables (clinical laboratory assessments).		Day 12	Yes
Primary	Safety variables (clinical laboratory assessments).		Clinical labs at follow up	Yes
Primary	Safety variables (adverse events)		Adverse events will colletected entire study	Yes
Primary	Safety variables (vital signs)		vital signs every hour during day 1	Yes
Primary	Safety variables (physical examination)		performed at screening	Yes
Primary	Safety variables (vital signs)		Vital Signs every hr during day 12	Yes
Primary	Safety variables (physical examination)		Performed at follow up	Yes
Primary	Safety variables (telemetry)		telemetry for 24hr. post dose day 1	Yes
Primary	Safety variables (telemetry)		telemetry for 24hr. post dose day 12	Yes
Primary	Safety variables (digital electrocardiograms (dECGs))		dECG during 5min, 13 times 24 hr after dose day 1	Yes
Primary	Safety variables (digital electrocardiograms (dECGs))		dECG during 5min, 13 times 24 hr after dose day 12	Yes
Primary	Safety variables (safety 12-lead paper electrocardiograms (pECG))		pECG at screening	Yes
Primary	Safety variables (safety 12-lead paper electrocardiograms (pECG))		pECG at follow up	Yes
Primary	Safety variables (clinical laboratory assessments).		clinical labs at screening	Yes
Primary	Safety variables (clinical laboratory assessments).		clinical labs day -3	Yes
Secondary	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	No
Secondary	Pharmacodynamic 11-ßHSD1 enzyme activity in adipose tissue		Information will be collected from the time of day -1 throuout the study	No
Secondary	Pharmacodynamic 11-ßHSD1 enzyme activity in the liver by measuring prednisolone generation		Information will be collected from day -1 to follow up	No
Secondary	To assess the effect on insulin after multiple doses of AZD8329		Information will be collected from day -2 to follow up	No
Secondary	To assess the effect on glucose after multiple doses of AZD8329		Information will be collected from day -2 to follow up	No
Secondary	To assess the effect on lipid variables after multiple doses of AZD8329		Information will be collected from day -2 to follow up	No