Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

Healthy Clinical Trial

Official title:

A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00687232
• Other study ID #: D3540C00010
• Status: Completed
• Phase: Phase 1
• First received: May 28, 2008
• Last updated: November 30, 2010
• Start date: January 2008
• Est. completion date: May 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Provision of informed consent

• Body Mass Index (BMI) between 18.0-27.0 kg/m2

• No clinically relevant abnormal findings

Exclusion Criteria:

• Acute illness which requires medical intervention

• Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.

• Clinical relevant disease or disorder (past or present)

• A history of respiratory disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD4818
Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days
• Placebo

Locations

Country	Name	City	State
Japan	Research Site	Osaka-city	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry		During the study	No
Primary	Lab assessment		During the study	No
Secondary	Pharmacokinetics		During the study	No