Healthy
Conditions
Keywords
Phase I, AZD3043, Japanese healthy volunteer
Brief summary
This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.
Interventions
DRUGAZD3043
Intravenous, single dose
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 with suitable veins for cannulation or repeated venepuncture. * Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2 * Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the Investigator.
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 * Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product. * Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B). | From screening period to follow-up visit 42 days (Maximum) |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK | Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) |
| To evaluate the onset, level and recovery of/from sedation/anaesthesia. | Assessed on Day 1 |
Countries
United Kingdom
Outcome results
None listed