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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01096004
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 7.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: AZD4017; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• 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
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD4017; oral suspension, 1200mg, once daily, for 10 days
Placebo Comparator: 2	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01096004
• Other Study ID Numbers: D2060M00001
• First Posted: Mar 30, 2010
• Last Update Posted: Dec 10, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Pharmacodynamic method evaluation

Study Results

No Results Posted as of Dec 10, 2010