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

Healthy Clinical Trial

Official title:

A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264250
• Other study ID #: D4120C00001
• Status: Completed
• Phase: Phase 1
• First received: December 7, 2010
• Last updated: May 23, 2011
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD2927
Single dose of AZD2927
• Placebo
Single dose of placebo

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of AZD2927, at screening		Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening	Yes
Primary	Safety and tolerability of AZD2927, day 1		Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1.	Yes
Primary	Safety and tolerability of AZD2927, day 2		Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2.	Yes
Primary	Safety and tolerability of AZD2927, day 3		Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3.	Yes
Primary	Safety and tolerability of AZD2927, at follow up		Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up.	Yes
Secondary	Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1		Pharmacokinetic sampling will be performed day 1	No
Secondary	Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2		Pharmacokinetic sampling will be performed day 2	No
Secondary	Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3		Pharmacokinetic sampling will be performed day 3	No