A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects (JSMAD)

AstraZeneca

Status and phase

Terminated

Phase 1

Conditions

Healthy

Treatments

Drug: AZD9164

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01096563

2009-015560-34 (EudraCT Number)

D1882C00004

Details and patient eligibility

About

This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.

Enrollment

27 estimated patients

Sex

All

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

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, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product