NCT01096004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2 months

First QC Date

March 29, 2010

Last Update Submit

December 9, 2010

Conditions

Obesity

Keywords

Pharmacodynamic method evaluation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL
Drug: AZD4017

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD4017DRUG

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

1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Obesity

Interventions

2-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per-Anders Jansson, Ass Prof, MD, PhD

    Avdelningen för molekylär och klinisk medicin Lundberglaboratoriet

    PRINCIPAL INVESTIGATOR

  • Mikaela Sjöstrand

    AstraZeneca

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 30, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

SE(1)