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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01096004
• Date of registration: 29/03/2010
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue
• Scientific title: A Randomised, Single-blind, Placebo-controlled, Single-centre, Phase I Study in Abdominally Obese Healthy Volunteers to Evaluate Methods to Assess 11-ßHSD1 Activity in Adipose Tissue and Related Downstream Biomarkers After Single and Repeated Oral Doses of AZD4017 for 10 Days
• Date of first enrolment: March 2010
• Target sample size: 15
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01096004
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
• Phase: Phase 1

Countries of recruitment

Sweden

Contacts

• Name: Mikaela Sjöstrand
• Affiliation: AstraZeneca

• Name: Per-Anders Jansson, Ass Prof, MD, PhD
• Affiliation: Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Drug: AZD4017

Drug: Placebo

Primary Outcome(s)

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 Outcome(s)

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]

Secondary ID(s)

D2060M00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors