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
  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 April 17, 2014