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Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021189
First Posted: November 26, 2009
Last Update Posted: June 10, 2010
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.
Information provided by:
AstraZeneca
  Purpose
The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.

Condition Intervention Phase
Healthy Drug: AZD1446 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG. [ Time Frame: During the whole study period, ca. 50 days. ]

Secondary Outcome Measures:
  • To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects. [ Time Frame: PK sampling taken at defined timepoints during residential period, 12 days. ]

Enrollment: 97
Study Start Date: December 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1446
Drug: AZD1446
Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.
Placebo Comparator: 2
Placebo
Drug: Placebo
Oral solution Dose single and followed by 7-day multiple dosing.

  Eligibility

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 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
  • BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

  • History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
  • History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.
  Contacts and Locations
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): NCT01021189


Locations
Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Björn Paulsson, MD, PhD AstraZeneca R&D Södertälje
Principal Investigator: Shunji Matsuki, MD, PhD Kyusyu Clinical Phramacology Research Clinic
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01021189     History of Changes
Other Study ID Numbers: D1950C00003
First Submitted: November 23, 2009
First Posted: November 26, 2009
Last Update Posted: June 10, 2010
Last Verified: June 2010

Keywords provided by AstraZeneca:
safety
tolerability
AZD1446
AD
Japanese