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

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ClinicalTrials.gov Identifier: NCT00687232
Recruitment Status : Completed
First Posted : May 30, 2008
Last Update Posted : December 1, 2010
Sponsor:
Information provided by:
AstraZeneca

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
AZD4818
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 ]


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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes 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

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 ClinicalTrials.gov identifier (NCT number): NCT00687232


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

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
First Posted: May 30, 2008    Key Record Dates
Last Update Posted: December 1, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Phase I
Japan
Japanese
inhalation