A Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD1446 Administered for 4 Weeks in Elderly Healthy Volunteers
- Registration Number
- NCT00997308
- Lead Sponsor
- AstraZeneca
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AZD1446 Low AZD1446 Low dose of AZD1446 Placebo Placebo - AZD1446 High AZD1446 High dose of AZD1446
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Research
🇸🇪Lund, Sweden