NCT01021189

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Dec 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 10, 2010

Status Verified

June 1, 2010

Enrollment Period

6 months

First QC Date

November 23, 2009

Last Update Submit

June 9, 2010

Conditions

Healthy

Keywords

safetytolerabilityAZD1446ADJapanese

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the whole study period, ca. 50 days.

Secondary Outcomes (1)

  • To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.

    PK sampling taken at defined timepoints during residential period, 12 days.

Study Arms (2)

1

EXPERIMENTAL

AZD1446

Drug: AZD1446

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD1446DRUG

Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.

1
PlaceboDRUG

Oral solution Dose single and followed by 7-day multiple dosing.

2

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Fukuoka, Japan

Location

MeSH Terms

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octane

Study Officials

  • Björn Paulsson, MD, PhD

    AstraZeneca R&D Södertälje

    STUDY DIRECTOR

  • Shunji Matsuki, MD, PhD

    Kyusyu Clinical Phramacology Research Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 23, 2009

First Posted

November 26, 2009

Study Start

December 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 10, 2010

Record last verified: 2010-06

Locations

JP(1)