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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: May 28, 2008
Last updated: November 30, 2010
Last verified: November 2010
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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 ]
  • Lab assessment [ Time Frame: During the study ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: During the study ]

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


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00687232

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

Responsible Party: Bengt Larsson/MD PhD, Medical Science Director, RITA EPT2, AstraZeneca Pharmaceuticals Identifier: NCT00687232     History of Changes
Other Study ID Numbers: D3540C00010
Study First Received: May 28, 2008
Last Updated: November 30, 2010

Keywords provided by AstraZeneca:
Phase I
inhalation processed this record on September 20, 2017