Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD1446

• Registration Number: NCT00803855
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-14
• Last Update Posted: 2009-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• physical healthy volunteers
• weight between 50 to 100 kg and a body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria

• History of any clinically significant disease or disorder.
• History of severe allergy/hypersensitivity reactions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD1446 Oral, with or without food	AZD1446	Single oral administration of AZD1446 with or without food
AZD1446 Oral or placebo	AZD1446	Single oral administration of AZD1446 or placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables	From first to last visit

Secondary Outcome Measures

Name	Time	Method
Determine the single ascending dose pharmacokinetics of AZD1446	PK sampling taken at defined timepoints during residential period
Determine the single dose of AZD1446 on food interaction	From first to last visit

Trial Locations

Locations (1)

Research site; 🇸🇪 Huddinge, Sweden