Healthy
Conditions
Keywords
safety, tolerability, pharmacokinetics, AZD2423, Japanese
Brief summary
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.
Interventions
DRUGAZD2423
oral solution
DRUGPlacebo
oral solution
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
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 * Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture * Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg * Clinically normal physical findings including supine blood pressure, 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(s), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer'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 * Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse events | Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) | — |
| Vital signs | Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) | Changes from baseline in systolic blood pressure, pulse rate and body temperature |
| Electrocardiograms | Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) | — |
| Laboratory Variables (hematology, urinalysis and clinical chemistry) | Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration over time | Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose |
Countries
Japan
Outcome results
None listed