AZD9164 Single Ascending Dose Study in Healthy Male Subjects

Healthy Clinical Trial

Official title:

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847249
• Other study ID #: D1882C00001
• Secondary ID: EudraCT No.2008-
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2009
• Last updated: September 22, 2009
• Start date: February 2009
• Est. completion date: April 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• AZD9164
Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.
• Placebo
Each subject will receive a single-dose.

Locations

Country	Name	City	State
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)		up to 48 hours post-dose.	Yes
Secondary	Pharmacokinetics		up to 48 hours post-dose.	No
Secondary	Local and extrapulmonary effects		up to 48 hours post-dose.	No