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

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AZD2927

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01264250

D4120C00001

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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