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A Single and Multiple Ascending Dose Study With AZD9164 Given for 13 Days in Healthy Male and Female Japanese Subjects (JSMAD)

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: NCT01096563
Recruitment Status : Terminated (Sponsor has taken the decision to terminate further development of the compound)
First Posted : March 31, 2010
Last Update Posted : December 3, 2010
Information provided by:

Brief Summary:
This is a single centre, Double blinded, Randomised, Placebo-controlled, Parallel group study to access the safety, tolerability, and pharmacokinetics of Inhaled AZD9164 after administration of single and Multiple Ascending doses in Japanese subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD9164 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Administration of Single and Multiple Ascending Doses for 13 Days in Healthy Male and Female Japanese Subjects
Study Start Date : March 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: 1
Drug: AZD9164

Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD).

The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose.

Placebo Comparator: 2 Drug: Placebo
Dry powder for inhalation via Turbuhaler, JSMAD.

Primary Outcome Measures :
  1. Safety measurements (ECG's, Telemetry, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ]

Secondary Outcome Measures :
  1. To investigate the pharmacokinetics (PK) of AZD9164 following inhaled administration of single and multiple ascending doses, by assessment of the dose proportionality, the degree of accumulation and the time linearity [ Time Frame: PK sampling during the residential period and intense PK sampling on day 1 and day 15 (up to 72 and 120 hours respectively) ]
  2. To investigate pharmacodynamic (PD) effects of inhaled single and multiple ascending doses of AZD9164, by assessment of lung function [ Time Frame: Spirometry during the residential stay on days 1, 4, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Healthy Japanese subjects with suitable veins for cannulation or repeated venipuncture
  • Have a body mass index (BMI) between 18 and 27 kg/m2 and a body weight between 50 and 85 kg
  • Male subjects should be willing to use barrier contraception ie, condoms with spermicide, from the first day of dosing until 3 months after the last dose of investigational product

Exclusion Criteria:

  • History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product

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): NCT01096563

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United Kingdom
Research Site
Croydon, United Kingdom
Sponsors and Collaborators
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Principal Investigator: Ulrike Lorch, MD MFPM FRCA Richmond Pharmacology Limited
Study Director: Carin Jorup AstraZeneca
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MSD, AstraZeneca Identifier: NCT01096563    
Other Study ID Numbers: D1882C00004
2009-015560-34 ( EudraCT Number )
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 2010
Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer