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

NCT ID: NCT01096004

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Keywords

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Pharmacodynamic method evaluation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type EXPERIMENTAL

AZD4017

Intervention Type DRUG

oral suspension, 1200mg, once daily, for 10 days

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AZD4017

oral suspension, 1200mg, once daily, for 10 days

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Per-Anders Jansson, Ass Prof, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet

Mikaela Sjöstrand

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D2060M00001

Identifier Type: -

Identifier Source: org_study_id