AZD9164 Single Ascending Dose Study in Healthy Male Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD9164; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00847249

D1882C00001

EudraCT No.2008-007188-18

Details and patient eligibility

About

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Enrollment: 65 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examinations
• Use of any prescribed or non-prescribed medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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65 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Solution for nebulisation, inhaled

Treatment:

Drug: AZD9164

2

Placebo Comparator group

Description:

Solution for nebulisation, inhaled

Treatment:

Drug: Placebo