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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: AZD9164; Drug: Placebo

• Registration Number: NCT01096563
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-30
• Study First Posted: 2010-03-31
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-02
• Last Update Posted: 2010-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD9164	AZD9164
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary Outcome Measures

Name	Time	Method
To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function	Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15
To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity	PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively)

Trial Locations

Locations (1)

Research Site; 🇬🇧 Croydon, United Kingdom