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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096004
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : December 10, 2010
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Drug: AZD4017 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2010
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Experimental: 1 Drug: AZD4017
oral suspension, 1200mg, once daily, for 10 days

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096004

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Research Site
Goteborg, Sweden
Sponsors and Collaborators
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Principal Investigator: Per-Anders Jansson, Ass Prof, MD, PhD Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet
Study Chair: Mikaela Sjöstrand AstraZeneca
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Responsible Party: MSD, AstraZeneca Identifier: NCT01096004    
Other Study ID Numbers: D2060M00001
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
Pharmacodynamic method evaluation