Study to Evaluate Methods That Assess the Effect of AZD4017 in Adipose Tissue
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01096004
First received: March 29, 2010
Last updated: December 9, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013