NCT00803855
Completed
Phase 1
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers
Overview
- Phase
- Phase 1
- Intervention
- AZD1446
- Conditions
- Healthy
- Sponsor
- AstraZeneca
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.
Investigators
Eligibility Criteria
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
Arms & Interventions
AZD1446 Oral or placebo
Single oral administration of AZD1446 or placebo
Intervention: AZD1446
AZD1446 Oral, with or without food
Single oral administration of AZD1446 with or without food
Intervention: AZD1446
Outcomes
Primary Outcomes
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables
Time Frame: From first to last visit
Secondary Outcomes
- 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)
Study Sites (1)
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