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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01096004
First received: March 29, 2010
Last updated: December 9, 2010
Last verified: December 2010
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01096004     History of Changes
Other Study ID Numbers: D2060M00001
Study First Received: March 29, 2010
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Pharmacodynamic method evaluation

ClinicalTrials.gov processed this record on September 30, 2014