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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713271
First Posted: July 11, 2008
Last Update Posted: April 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]
  • Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab [ Time Frame: Before, during and after dosing ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Before, during and after dosing ]
  • Potassium and lactate concentrations [ Time Frame: Before, during and after dosing ]
  • Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1 [ Time Frame: Before, during and after dosing ]

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
Experimental: 1
Low dose
Drug: AZD3199

Low dose

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

Experimental: 2
intermediate dose
Drug: AZD3199

intermediate dose

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

Experimental: 3
high dose
Drug: AZD3199

high dose

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

Placebo Comparator: 4 Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713271


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

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00713271     History of Changes
Other Study ID Numbers: D0570C00002
First Submitted: July 9, 2008
First Posted: July 11, 2008
Last Update Posted: April 10, 2014
Last Verified: April 2014

Keywords provided by AstraZeneca:
Healthy male
tolerability
safety
inhalation

Additional relevant MeSH terms:
AZD-3199
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs