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NCT00803855 Clinical Trial

Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

Healthy Clinical Trial

— SAD  

Official title:
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00803855
Other study ID # D1950C00001
Secondary ID EudraCT No.: 200
Status Completed
Phase Phase 1
First received December 5, 2008
Last updated May 14, 2009
Start date December 2008
Est. completion date April 2009

Study information
Verified date May 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- physical healthy volunteers

- weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria:

- History of any clinically significant disease or disorder.

- History of severe allergy/hypersensitivity reactions

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AZD1446
oral, single dose

Locations
Country Name City State
Sweden Research site Huddinge

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 AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables From first to last visit Yes
Secondary Determine the single ascending dose pharmacokinetics of AZD1446 PK sampling taken at defined timepoints during residential period No
Secondary Determine the single dose of AZD1446 on food interaction From first to last visit No
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