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Completed

NCT Number: NCT01207089

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

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.

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Key information

Conditions

Overweight Body Weight Healthy Male Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD8329

Drug

AZD8329 Oral Solution 20mg/ml

Placebo

Drug

Placebo AZD8329 Oral Solution

Primary outcomes

  1. Safety variables (adverse events).

    Time frame: Adverse events day -1

  2. Safety variables (adverse events).

    Time frame: Adverse events will colletected entire study

  3. Safety variables (clinical laboratory assessments).

    Time frame: Clinical labs day 1

  4. Safety variables (clinical laboratory assessments).

    Time frame: Day 4

  5. Safety variables (clinical laboratory assessments).

    Time frame: Day 8

  6. Safety variables (clinical laboratory assessments).

    Time frame: Day 12

  7. Safety variables (clinical laboratory assessments).

    Time frame: Clinical labs at follow up

  8. Safety variables (adverse events)

    Time frame: Adverse events will colletected entire study

  9. Safety variables (vital signs)

    Time frame: vital signs every hour during day 1

  10. Safety variables (physical examination)

    Time frame: performed at screening

  11. Safety variables (vital signs)

    Time frame: Vital Signs every hr during day 12

  12. Safety variables (physical examination)

    Time frame: Performed at follow up

  13. Safety variables (telemetry)

    Time frame: telemetry for 24hr. post dose day 1

  14. Safety variables (telemetry)

    Time frame: telemetry for 24hr. post dose day 12

  15. Safety variables (digital electrocardiograms (dECGs))

    Time frame: dECG during 5min, 13 times 24 hr after dose day 1

  16. Safety variables (digital electrocardiograms (dECGs))

    Time frame: dECG during 5min, 13 times 24 hr after dose day 12

  17. Safety variables (safety 12-lead paper electrocardiograms (pECG))

    Time frame: pECG at screening

  18. Safety variables (safety 12-lead paper electrocardiograms (pECG))

    Time frame: pECG at follow up

  19. Safety variables (clinical laboratory assessments).

    Time frame: clinical labs at screening

  20. Safety variables (clinical laboratory assessments).

    Time frame: clinical labs day -3

Secondary outcomes

  1. 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

  2. Pharmacodynamic 11-βHSD1 enzyme activity in adipose tissue

    Time frame: Information will be collected from the time of day -1 throuout the study

  3. Pharmacodynamic 11-βHSD1 enzyme activity in the liver by measuring prednisolone generation

    Time frame: Information will be collected from day -1 to follow up

  4. To assess the effect on insulin after multiple doses of AZD8329

    Time frame: Information will be collected from day -2 to follow up

  5. To assess the effect on glucose after multiple doses of AZD8329

    Time frame: Information will be collected from day -2 to follow up

  6. To assess the effect on lipid variables after multiple doses of AZD8329

    Time frame: Information will be collected from day -2 to follow up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: AZ8329

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2010
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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