A Study to Assess the Safety, Tolerability and Pharmacokinetics of Modified-Release Formulations of AZD1446 After Oral Single and Repeated Doses

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1446; Drug: Placebo

• Registration Number: NCT01199315
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD1446 in young and elderly healthy Japanese volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-16
• Last Update Posted: 2011-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy Japanese volunteers, aged ≥20 to ≤50 years for male young volunteers, ≥65 to ≤80 years for male or post-menopausal female elderly volunteers.
• 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 severe allergy/hypersensitivity reactions including drug-allergy or drug hypersensitivity reactions, or ongoing allergy/hypersensitivity.
• History or present symptoms or signs of Quincke oedema, angiooedema, or urticaria pigmentosa, or history of repeated episodes of urticaria.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1446	Oral capsule. Dose single and followed by 5-day repeated dosing. Specific doses depend on panel.
2	Placebo	Oral capsule. Dose single and followed by 5-day repeated dosing.

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of AZD1446 following single and repeated doses of an orally administered MR capsule of AZD1446 in healthy young and elderly Japanese volunteers by adverse events, vital signs, laboratory variables and ECG.	During the whole study period, ca. 50 days

Secondary Outcome Measures

Name	Time	Method
To determine PK of AZD1446 following single and repeated doses of AZD1446 MR capsule in healthy young and elderly Japanese volunteers.	PK samplings are taken at defined timepoints during residential period, 10 days.

Trial Locations

Locations (1)

Research Site; 🇯🇵 Fukuoka, Japan