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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)

This study has been terminated.
(Sponsor has taken the decision to terminate further development of the compound)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01096563
First received: March 25, 2010
Last updated: December 2, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: AZD9164
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: March 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD9164
 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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096563

Locations
United Kingdom
Research Site
Croydon, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ulrike Lorch, MD MFPM FRCA Richmond Pharmacology Limited
Study Director: Carin Jorup AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01096563     History of Changes
Other Study ID Numbers: D1882C00004, 2009-015560-34
Study First Received: March 25, 2010
Last Updated: December 2, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
Phase I
Japanese healthy volunteer
AZD9164

ClinicalTrials.gov processed this record on October 17, 2012