Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men (AZD3199MAD)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 9, 2008
Last updated: April 9, 2014
Last verified: April 2014
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: Double Blind (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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00713271

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

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00713271     History of Changes
Other Study ID Numbers: D0570C00002
Study First Received: July 9, 2008
Last Updated: April 9, 2014

Keywords provided by AstraZeneca:
Healthy male

Additional relevant MeSH terms:
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 28, 2017