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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: AZD3199; Drug: Placebo

• Registration Number: NCT00713271
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-09
• Study First Submitted QC: 2008-07-10
• Study First Posted: 2008-07-11
• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-09
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

• BMI 19-30, weight 60-100 kg
• Non/ex-smokers, Non/ex-nicotine users

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Exclusion Criteria

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings at screening examinations
• Use of any prescribed or non-prescribed medication

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD3199	Low dose
2	AZD3199	intermediate dose
3	AZD3199	high dose
4	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Potassium and lactate concentrations	Before, during and after dosing
Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1	Before, during and after dosing
Pharmacokinetics	Before, during and after dosing

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden