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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096004
• Other study ID #: D2060M00001
• Status: Completed
• Phase: Phase 1
• First received: March 29, 2010
• Last updated: December 9, 2010
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• AZD4017
oral suspension, 1200mg, once daily, for 10 days
• Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation		A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.	No
Secondary	Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables		The variables will be measure predose and the repeatedly during the following 10 days after dosing	Yes