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

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00713271
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: AZD3199; Drug: Placebo; Drug: AZD3199; Drug: AZD3199	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (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
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Incidence and nature of Adverse Events [Before, during and after dosing]

2. Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab [Before, during and after dosing]

Secondary Outcome Measures

1. Pharmacokinetics [Before, during and after dosing]

2. Potassium and lactate concentrations [Before, during and after dosing]

3. Tremor, palpitations, heart rate, QTc, pulse and blood pressure and FEV1 [Before, during and after dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Lund		Sweden

Sponsors and Collaborators

• AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• CSR-D0570C00002.pdf

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00713271
• Other Study ID Numbers: D0570C00002
• First Posted: Jul 11, 2008
• Last Update Posted: Apr 10, 2014
• Last Verified: Apr 1, 2014

• Keywords provided by AstraZeneca: Healthy male; tolerability; safety; inhalation
• Additional relevant MeSH terms: AZD-3199

Study Results

No Results Posted as of Apr 10, 2014