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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01207089
First received: September 14, 2010
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Overweight
Healthy
Male
Drug: AZD8329
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue [ Time Frame: Information will be collected from the time of day -1 throuout the study ] [ Designated as safety issue: No ]
  • Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation [ Time Frame: Information will be collected from day -1 to follow up ] [ Designated as safety issue: No ]
  • To assess the effect on insulin after multiple doses of AZD8329 [ Time Frame: Information will be collected from day -2 to follow up ] [ Designated as safety issue: No ]
  • To assess the effect on glucose after multiple doses of AZD8329 [ Time Frame: Information will be collected from day -2 to follow up ] [ Designated as safety issue: No ]
  • To assess the effect on lipid variables after multiple doses of AZD8329 [ Time Frame: Information will be collected from day -2 to follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
Placebo AZD8329 Oral Solution
Experimental: 2
AZD8329
Drug: AZD8329
AZD8329 Oral Solution 20mg/ml

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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207089

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01207089     History of Changes
Other Study ID Numbers: D2350C00010
Study First Received: September 14, 2010
Last Updated: May 9, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Safety
tolerability
PK
healthy
overweight
obese

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014