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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00713271
First received: July 9, 2008
Last updated: April 9, 2014
Last verified: April 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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
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

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
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 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

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00713271     History of Changes
Other Study ID Numbers: D0570C00002
Study First Received: July 9, 2008
Last Updated: April 9, 2014
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Healthy male
tolerability
safety
inhalation

ClinicalTrials.gov processed this record on August 01, 2014