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OpenTrials
Completed

NCT Number: NCT00687232

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

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

Completed

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Key information

Conditions

Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Osaka, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD4818

Drug

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

Placebo

Drug

Primary outcomes

  1. Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry

    Time frame: During the study

  2. Lab assessment

    Time frame: During the study

Secondary outcomes

  1. Pharmacokinetics

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 30, 2008
Registry last updated
Dec 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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