Healthy
Conditions
Keywords
safety, tolerability, AZD1446, AD, ADHD, Japanese
Brief summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.
Interventions
DRUGAZD1446
oral capsule, Moderate Release
DRUGPlacebo
oral capsule
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers. * BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).
Exclusion criteria
* History of severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity. * History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG. | During the whole study period, ca. 50 days |
Secondary
| Measure | Time frame |
|---|---|
| To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers. | PK samplings are taken at defined timepoints during residential period, 10 days. |
Countries
Japan
Outcome results
None listed