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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00997308

First received: October 12, 2009

Last updated: January 21, 2010

Last verified: January 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2009

Last Updated Date

January 21, 2010

Start Date ^ICMJE

October 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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). [ Time Frame: 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). ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00997308 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: PK sampling taken at defined timepoints during the treatment period (study days 1-28) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: AZD1446
Solution, oral, for 4 weeks
Drug: Placebo

Study Arm (s)

Experimental: AZD1446 Low
Low dose of AZD1446

Intervention: Drug: AZD1446
Experimental: AZD1446 High
High dose of AZD1446

Intervention: Drug: AZD1446
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

65 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00997308

Other Study ID Numbers ^ICMJE

D1950C00009, EudraCT No.2009-013390-18

Has Data Monitoring Committee

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Bo Fransson, MD, PhD	AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden
Study Director:	Björn Paulsson, MD, PhD	AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden

Information Provided By

AstraZeneca

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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