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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01096004
First Posted: March 30, 2010
Last Update Posted: December 10, 2010
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Obesity Drug: AZD4017 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 15
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD4017
oral suspension, 1200mg, once daily, for 10 days
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01096004


Locations
Sweden
Research Site
Goteborg, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Per-Anders Jansson, Ass Prof, MD, PhD Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet
Study Chair: Mikaela Sjöstrand AstraZeneca
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01096004     History of Changes
Other Study ID Numbers: D2060M00001
First Submitted: March 29, 2010
First Posted: March 30, 2010
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Pharmacodynamic method evaluation

Additional relevant MeSH terms:
Niacinamide
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs