AZD Single Ascending Dose Study In Healthy Japanese Subjects (JSAD)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: AZD3043

Study type

Interventional

Funder types

Industry

Identifiers

NCT01028040

D0510C00004

Details and patient eligibility

About

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.

Enrollment

72 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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