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

November 23, 2009
June 9, 2010
December 2009
June 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01021189 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: AZD1446
    Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.
  • Drug: Placebo
    Oral solution Dose single and followed by 7-day multiple dosing.
  • Experimental: 1
    AZD1446
    Intervention: Drug: AZD1446
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01021189
D1950C00003
No
MSD, AstraZeneca
AstraZeneca
Not Provided
Study Director: Björn Paulsson, MD, PhD AstraZeneca R&D Södertälje
Principal Investigator: Shunji Matsuki, MD, PhD Kyusyu Clinical Phramacology Research Clinic
AstraZeneca
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP