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To Assess the Safety, Tolerability, Pharmacokinetics and Pharmakodynamics of AZD2820 After Multiple Ascending Doses

NCT ID: NCT01469923

Last Updated: 2012-07-24

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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This is a randomised and single-blind, placebo-controlled study to investigate the safety, tolerabilty, pharmacokinetics and pharmacodynamics of repeated and ascending doses of AZD2820 to obese but otherwise healthy male subjects.

Detailed Description

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A Phase I, Single Centre, Single-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2820 after Administration of Multiple Ascending Doses.

Conditions

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Obesity

Keywords

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Phase 1 obese healthy male volunteers multiple doses dose escalation pharmacokinetics pharmakodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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AZD2820

AZD2820 multiple injections

Group Type ACTIVE_COMPARATOR

AZD2820

Intervention Type DRUG

Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen

Placebo for AZD2820

Placebo for AZD2820 multiple injections

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ascending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen

Interventions

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AZD2820

Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen

Intervention Type DRUG

Placebo

Ascending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures including the genetic sampling and analyses
* Obese but otherwise healthy male subjects aged 18 - 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 27 and 40 kg/m2

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the stud
* A history of erectile dysfunction or anatomic abnormality of the penis (eg, cavernosal fibrosis, Peyronie's disease, or plaques) which interferes with normal erectile function
* Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2820
* Any clinically significant abnormalities in clinical chemistry, haematology (including eosinophilia) or urinalysis results as judged by the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Ritter, BM BCH, MRCP, FRCP

Role: PRINCIPAL_INVESTIGATOR

QLON

Mark Berner Hansen, PHD

Role: STUDY_DIRECTOR

AstraZeneca Mölndal, Sweden

Mirjana Kujacic, PHD

Role: STUDY_CHAIR

AstraZeneca Mölndal, Sweden

Locations

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Research site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D3870C00002

Identifier Type: -

Identifier Source: org_study_id