A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers

Healthy Clinical Trial

Official title:

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group, Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Elderly Male and Female Volunteers During 4 Weeks of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997308
• Other study ID #: D1950C00009
• Secondary ID: EudraCT No.2009-
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2009
• Last updated: January 21, 2010
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• 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

This study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of two doses of AZD1446 or placebo in subjects when given for 4 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Male or non-fertile female, elderly Subjects, aged =65 to =85

• Body mass index (BMI) between 18 and 30 kg/m2

• Clinically normal findings on physical examination

Exclusion Criteria:

• History of any clinically significant disease or disorder

• History of severe allergy/hypersensitivity reactions including severe food allergy 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:
• AZD1446
Solution, oral, for 4 weeks
• Placebo

Locations

Country	Name	City	State
Sweden	Research	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the safety and tolerability of AZD1446 dosed for 4 weeks as compared to placebo in healthy elderly male and female volunteers. Safety and tolerability outcomes include adverse events, clinical chemistry and vitals (pulse and blood pressure).		During the whole study period, Study days 1-68 (30 days of enrolment , study day 1-28 and follow up visit study days 35-38).	Yes
Secondary	To determine the PK of AZD1446 dosed for 4 weeks in healthy elderly male and female volunteers. PK parameters include renal clearance, AUC (0-24)ss and T1/2 eff.		PK sampling taken at defined timepoints during the treatment period (study days 1-28)	No