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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01096004

Enrollment

Registered

2010-03-30

Start date

2010-03-31

Completion date

2010-05-31

Last updated

2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Pharmacodynamic method evaluation

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.

Interventions

DRUGAZD4017

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
To investigate the effect of single and repeated doses of AZD4017 and placebo on mechanisms in adipose tissue involved in metabolic regulation	A adipose tissue biospy is taken at baseline, on first day of dosing day, on 4th dosing day and on 9th dosing day.

Secondary

Measure	Time frame
Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables	The variables will be measure predose and the repeatedly during the following 10 days after dosing

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026