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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00687232
First received: May 28, 2008
Last updated: November 30, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: AZD4818
Drug: Placebo
 Phase 1

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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Lab assessment [ Time Frame: During the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: During the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD4818
 Drug: AZD4818
Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687232

Locations
Japan
Research Site
Osaka-city, Osaka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Michio Yagi Osaka Pharmacology Clinical Research Hospital
  More Information

No publications provided

Responsible Party: Bengt Larsson/MD PhD, Medical Science Director, RITA EPT2, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00687232     History of Changes
Other Study ID Numbers: D3540C00010
Study First Received: May 28, 2008
Last Updated: November 30, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
Phase I
Japan
Japanese
inhalation

ClinicalTrials.gov processed this record on May 19, 2013