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Completed

NCT Number: NCT00772759

Assess Safety, Tolerability and PK of AZD3199 in Japanese

The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis). The secondary objectives of the study are to investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by assessment of the degree of accumulation, dose proportionality and time linearity in healthy Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single and multiple ascending doses of AZD3199 by assessment of potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and FEV1.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Slough, Berkshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years.
  • BMI 18 - 27, Weight 50 - 85 kg
  • Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
  • Clinical normal physical findings

Exclusion criteria

  • Any clinically significant disease or disorder
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
  • Use of any medication (including OTC), herbal preparations, vitamins or nutritional supplements within 2 weeks prior to Visit 2, except for occasional intake of paracetamol (maximum daily dose of 4 g)

Treatment and study plan

AZD3199 Turbuhaler®

Drug

240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)

Placebo Turbuhaler®

Drug

single and multiple (o.d. for 12 days)

Primary outcomes

  1. Safety/Tolerability - adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis)

    Time frame: During the study

Secondary outcomes

  1. Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199.

    Time frame: During residential period

  2. Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1).

    Time frame: During residential period

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 Single and Multiple Ascending Doses of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Japanese Healthy Men

Important dates

Study start
2008
Study completion
2009
First posted
Oct 15, 2008
Registry last updated
May 5, 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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