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OpenTrials
Completed

NCT Number: NCT01096004

Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue

The primary purpose of this study is to investigate different methods to evaluate the effect of AZD4017 in adipose tissue after single and multiple doses of AZD4017 in abdominally obese but otherwise healthy subjects.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Provision of signed written and dated informed consent
  • Have a body mass index (BMI) between 27 and 35 kg/m2
  • Waist circumference of >102 cm

Exclusion criteria

  • History of any clinical significant disease
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
  • Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

Treatment and study plan

AZD4017

Drug

oral suspension, 1200mg, once daily, for 10 days

Placebo

Drug

Primary outcomes

  1. To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation

    Time frame: A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.

Secondary outcomes

  1. Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables

    Time frame: The variables will be measure predose and the repeatedly during the following 10 days after dosing

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Single-blind, Placebo-controlled, Single-centre, Phase I Study in Abdominally Obese Healthy Volunteers to Evaluate Methods to Assess 11-βHSD1 Activity in Adipose Tissue and Related Downstream Biomarkers After Single and Repeated Oral Doses of AZD4017 for 10 Days

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 30, 2010
Registry last updated
Dec 10, 2010

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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