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

April 9, 2014 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Low dose
Drug: AZD3199

Low dose

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

Drug: AZD3199

intermediate dose

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

Drug: AZD3199

high dose

Dry powder for inhalation, o.d., 1+12 days
Experimental: 2
intermediate dose
Drug: AZD3199

Low dose

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

Drug: AZD3199

intermediate dose

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

Drug: AZD3199

high dose

Dry powder for inhalation, o.d., 1+12 days
Experimental: 3
high dose
Drug: AZD3199

Low dose

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

Drug: AZD3199

intermediate dose

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

Drug: AZD3199

high dose

Dry powder for inhalation, o.d., 1+12 days
Placebo Comparator: 4
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and nature of Adverse Events
Time Frame: Before, during and after dosing
Before, during and after dosing
Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab
Time Frame: Before, during and after dosing
Before, during and after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: Before, during and after dosing
Before, during and after dosing
Potassium and lactate concentrations
Time Frame: Before, during and after dosing
Before, during and after dosing
Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1
Time Frame: Before, during and after dosing
Before, during and after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Gabriella Samuelsson Palmgren, AZ CPU Lund, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

July 9, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0570C00002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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