AZD9164 Single Ascending Dose Study in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD9164; Drug: Placebo

• Registration Number: NCT00847249
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Study Completion: 2009-04
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-22
• Last Update Posted: 2009-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD9164	Solution for nebulisation, inhaled
2	Placebo	Solution for nebulisation, inhaled

Primary Outcome Measures

Name	Time	Method
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)	up to 48 hours post-dose.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	up to 48 hours post-dose.
Local and extrapulmonary effects	up to 48 hours post-dose.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden