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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: AZD4818

• Registration Number: NCT00687232
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-29
• Study First Posted: 2008-05-30
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Provision of informed consent
• Body Mass Index (BMI) between 18.0-27.0 kg/m2
• No clinically relevant abnormal findings

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	AZD4818	AZD4818

Primary Outcome Measures

Name	Time	Method
Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry	During the study
Lab assessment	During the study

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	During the study

Trial Locations

Locations (1)

Research Site; 🇯🇵 Osaka-city, Osaka, Japan