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OpenTrials
Completed

NCT Number: NCT00713271

Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men

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Key information

Conditions

Healthy Volunteers 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

  • BMI 19-30, weight 60-100 kg
  • Non/ex-smokers, Non/ex-nicotine users

Exclusion criteria

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

Treatment and study plan

AZD3199

Drug

Low dose

Dry powder for inhalation, o.d., 1+12 days

Placebo

Drug

Primary outcomes

  1. Incidence and nature of Adverse Events

    Time frame: Before, during and after dosing

  2. Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab

    Time frame: Before, during and after dosing

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Before, during and after dosing

  2. Potassium and lactate concentrations

    Time frame: Before, during and after dosing

  3. Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1

    Time frame: Before, during and after dosing

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD3199 (a B2-agonist) Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men

Acronym: AZD3199MAD

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Apr 10, 2014

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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