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Completed

NCT Number: NCT00847249

AZD9164 Single Ascending Dose Study in Healthy Male Subjects

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.

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Key information

Conditions

Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Lund, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9164

Drug

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

Drug

Each subject will receive a single-dose.

Primary outcomes

  1. Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

    Time frame: up to 48 hours post-dose.

Secondary outcomes

  1. Pharmacokinetics

    Time frame: up to 48 hours post-dose.

  2. Local and extrapulmonary effects

    Time frame: up to 48 hours post-dose.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Feb 19, 2009
Registry last updated
Sep 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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