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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803855

D1950C00001

EudraCT No.: 2008-006228-76

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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110 participants in 2 patient groups

AZD1446 Oral or placebo

Experimental group

Description:

Single oral administration of AZD1446 or placebo

Treatment:

Drug: AZD1446

AZD1446 Oral, with or without food

Experimental group

Description:

Single oral administration of AZD1446 with or without food

Treatment:

Drug: AZD1446