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

Healthy Volunteers Clinical Trial

— AZD3199MAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713271
• Other study ID #: D0570C00002
• Status: Completed
• Phase: Phase 1
• First received: July 9, 2008
• Last updated: April 9, 2014
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AZD3199
Low dose Dry powder for inhalation, o.d., 1+12 days
• Placebo

• AZD3199
intermediate dose Dry powder for inhalation, o.d., 1+12 days
• AZD3199
high dose Dry powder for inhalation, o.d., 1+12 days

Locations

Country	Name	City	State
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of Adverse Events		Before, during and after dosing	No
Primary	Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab		Before, during and after dosing	No
Secondary	Pharmacokinetics		Before, during and after dosing	No
Secondary	Potassium and lactate concentrations		Before, during and after dosing	No
Secondary	Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1		Before, during and after dosing	No

External Links

•   Link
•   CSR-D0570C00002.pdf