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

NCT ID: NCT01332214

Last Updated: 2011-11-21

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-11-30

Brief Summary

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This is a randomised, single-blind, placebo-controlled Phase I study to investigate the safety, tolerability and pharmacokinetics after administration of single doses of AZD2820 to healthy male subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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Phase 1 healthy male volunteers dose escalation pharmacokinetics Single Ascending Dose AZD2820 Cmax tmax t1/2λz

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

Group Type EXPERIMENTAL

AZD2820

Intervention Type DRUG

Subcutaneous Injection in abdomen or Thigh

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous Injection in abdomen or Thigh

Interventions

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AZD2820

Subcutaneous Injection in abdomen or Thigh

Intervention Type DRUG

Placebo

Subcutaneous Injection in abdomen or Thigh

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.
* Healthy male subjects aged ≥20 - ≤45 years with suitable veins for cannulation or repeated venepuncture.
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
* Have a body mass index (BMI) between≥ 18 and ≤30 kg/m2 and weigh at least 50 kg and no more than 100 kg.
* Provision of signed, written and dated informed consent for genetic research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.

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 study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* 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
* Predisposition or history of priapism (eg, sickle cell anemia or trait).
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product
Minimum Eligible Age

20 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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Mirjana Kujacic, PhD

Role: STUDY_CHAIR

AstraZeneca

Prof J Ritter BM BCh, MRCP, FRCP

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Mark Berner Hansen, PhD

Role: STUDY_DIRECTOR

AstraZeneca

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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D3870C00001

Identifier Type: -

Identifier Source: org_study_id