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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021189
• Other study ID #: D1950C00003
• Status: Completed
• Phase: Phase 1
• First received: November 23, 2009
• Last updated: June 9, 2010
• Start date: December 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD1446
Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.
• Placebo
Oral solution Dose single and followed by 7-day multiple dosing.

Locations

Country	Name	City	State
Japan	Research Site	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	No