Healthy
Conditions
Keywords
AZD5213, safety, pharmacokinetics, single dose, repeated dose, young, elderly, Japanese, healthy subject
Brief summary
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD5213 in healthy young and elderly Japanese subjects
Interventions
DRUGAZD5213
Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days
DRUGPlacebo
Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of signed and dated, written informed consent prior to any study specific procedures * Japanese healthy male subjects aged 20 to 45 years (young) and male and female subjects aged 65 to 80 years (elderly) * Male subjects should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after the last dose of investigational product * Have a body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg * Clinically normal physical findings, supine BP, pulse rate, ECG and laboratory assessments in relation to age, as judged by the investigator(s)
Exclusion criteria
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs * History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, and personality disorder including borderline according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders * History of psychotic disorder among first degree relatives. * History of use of antipsychotic, antidepressant or anxiolytic drugs, prescribed as well as non-prescribed use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of AZD5213 by assessment of adverse event, vital signs, laboratory parameters and electrocardiograms (ECGs). | Range of Days 1-12 |
Secondary
| Measure | Time frame |
|---|---|
| To assess the PK of AZD5213 after a single and multiple doses by assessment of Cmax. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of fe. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of CLR. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of AUC. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of t1/2. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of tmax. | Range of Days 1-12 |
| To assess the PK of AZD5213 after a single and multiple doses by assessment of CL/F. | Range of Days 1-12 |
Countries
Japan
Outcome results
None listed