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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00687232
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : December 1, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD4818 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Arm Intervention/treatment
Experimental: 1
Drug: AZD4818
Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

Placebo Comparator: 2 Drug: Placebo

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetics [ Time Frame: During the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00687232

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

Responsible Party: Bengt Larsson/MD PhD, Medical Science Director, RITA EPT2, AstraZeneca Pharmaceuticals Identifier: NCT00687232     History of Changes
Other Study ID Numbers: D3540C00010
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Phase I