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Completed

NCT Number: NCT00997308

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

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.

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Key information

Conditions

Healthy

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AZD1446

Drug

Solution, oral, for 4 weeks

Placebo

Drug

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).

    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).

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.

    Time frame: PK sampling taken at defined timepoints during the treatment period (study days 1-28)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2009
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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