NCT00997308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

2 months

First QC Date

October 12, 2009

Last Update Submit

January 21, 2010

Conditions

Healthy

Keywords

AZD1446to investigate safety and tolerability in Healthy subjects during 4 weeks of administration

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

  • 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)

Study Arms (3)

AZD1446 Low

EXPERIMENTAL

Low dose of AZD1446

Drug: AZD1446

AZD1446 High

EXPERIMENTAL

High dose of AZD1446

Drug: AZD1446

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AZD1446DRUG

Solution, oral, for 4 weeks

AZD1446 HighAZD1446 Low
PlaceboDRUG
Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of any clinically significant disease or disorder
  • History of severe allergy/hypersensitivity reactions including severe food allergy as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research

Lund, Sweden

Location

MeSH Terms

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane

Study Officials

  • Bo Fransson, MD, PhD

    AstraZeneca R&DClinical Pharmacology Unit CPUTunavägen 22aS-221 87 LundSweden

    PRINCIPAL INVESTIGATOR

  • Björn Paulsson, MD, PhD

    AstraZeneca R&D SödertäljeSE-151 85 SödertäljeSweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2009

First Posted

October 19, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

SE(1)