Healthy
Conditions
Keywords
Phase I, Japan, Elderly, PK, SAD, MAD
Brief summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
Interventions
DRUGTC-5214
Tablet, Oral, twice daily
DRUGPlacebo
Tablet, Oral, twice daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Japanese healthy elderly male and female ≥65 years old. * Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg. * Be able to understand and comply with the requirements of the study as judged by the investigator(s).
Exclusion criteria
* History of any clinically significant medical or neurologic disease or disorder. * History of gastrointestinal surgery or unintentional rapid weight loss. * Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS. | During the whole study period, ca. 50 days |
Secondary
| Measure | Time frame |
|---|---|
| characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers. | PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part. |
Countries
Japan
Outcome results
None listed