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Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men (AZD3199MAD)
This study has been completed.
First Received: July 9, 2008   Last Updated: April 21, 2009   History of Changes
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00713271
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: AZD3199
Drug: Placebo
 Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence and nature of Adverse Events [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
  • Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
  • Potassium and lactate concentrations [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
  • Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1 [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 27
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Low dose
Drug: AZD3199
Low dose Dry powder for inhalation, o.d., 1+12 days
2: Experimental
intermediate dose
Drug: AZD3199
intermediate dose Dry powder for inhalation, o.d., 1+12 days
3: Experimental
high dose
Drug: AZD3199
high dose Dry powder for inhalation, o.d., 1+12 days
4: Placebo Comparator Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713271

Locations
Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Gabriella Samuelsson Palmgren AZ CPU Lund, Sweden
  More Information

No publications provided

Responsible Party: AstraZeneca R&D ( Lars Grundemar, MD, Medical Science Director, Emerging Respiratory 3 )
Study ID Numbers: D0570C00002
Study First Received: July 9, 2008
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00713271     History of Changes
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Healthy male
tolerability
safety
inhalation

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on May 07, 2009



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