A Study of Single and Multiple Ascending Doses of TC-5214 in Japanese Healthy Elderly Male and Female Volunteers
- Registration Number
- NCT01392820
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TC-5214 TC-5214 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
🇯🇵Fukuoka, Japan