A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers

NCT ID: NCT01264250

Last Updated: 2011-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-05-31

Brief Summary

In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

AZD2927

Intervention Type: DRUG

Single dose of AZD2927

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose of placebo

Interventions

AZD2927

Single dose of AZD2927

Intervention Type: DRUG

Placebo

Single dose of placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male subjects aged 18 to 45 years inclusive 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 (IP)
• Have a body mass index (BMI) between 19.0 and 30.0 kg/m2 and weight of at least 50.0 kg and no more than 100.0 kg

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, mental, cardiac, hepatic or renal disorder, or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
• Abnormal vital signs, after 10 minutes supine rest
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of IP
• Any clinically significant abnormalities in clinical chemistry, haematology 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

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca

Principal Investigators

Wolfgang Kühn, MD

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB

Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca

Mirjana Kujacic, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

Locations

Research Site

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

D4120C00001

Identifier Type: -

Identifier Source: org_study_id