A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

Healthy Men Clinical Trial

Official title:

A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00935662
• Other study ID #: D2350C00001
• Secondary ID: EudraCT No. 2009
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2009
• Last updated: September 10, 2010
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures

• Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

• 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 result of the study, or the subject´s ability to participate

• Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator

• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Study Design

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

Related Conditions & MeSH terms

• Healthy Men

Intervention

Drug:
• AZD8329
Oral solution, single ascending doses
• Placebo
Oral solution, placebo

Locations

Country	Name	City	State
Sweden	Research Site	Linköping
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 measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)		Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study.	Yes
Secondary	PK samples for AZD8329		Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose.	No