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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01021189
First received: November 23, 2009
Last updated: June 9, 2010
Last verified: June 2010
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: Yes ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01021189     History of Changes
Other Study ID Numbers: D1950C00003
Study First Received: November 23, 2009
Last Updated: June 9, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
safety
tolerability
AZD1446
AD
Japanese

ClinicalTrials.gov processed this record on May 16, 2013