Assess Safety, Tolerability and PK of AZD3199 in Japanese

NCT ID: NCT00772759

Last Updated: 2009-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-02-28

Brief Summary

The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in healthy male Japanese subjects by assessment of incidence and nature of adverse events (AEs), clinically significant abnormalities in ECG parameters, blood pressure (BP), pulse rate, lung function parameters, body temperature and laboratory variables (clinical chemistry, haematology and urinalysis). The secondary objectives of the study are to investigate the pharmacokinetics (PK) of single and multiple ascending doses of AZD3199 by assessment of the degree of accumulation, dose proportionality and time linearity in healthy Japanese subjects, and to investigate systemic β 2- adrenoreceptor mediated effects of single and multiple ascending doses of AZD3199 by assessment of potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure and FEV1.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Dry powder for oral inhalation

Group Type: EXPERIMENTAL

AZD3199 Turbuhaler®

Intervention Type: DRUG

240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)

2

Dry powder for oral inhalation

Group Type: PLACEBO_COMPARATOR

Placebo Turbuhaler®

Intervention Type: DRUG

single and multiple (o.d. for 12 days)

Interventions

AZD3199 Turbuhaler®

240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)

Intervention Type: DRUG

Placebo Turbuhaler®

single and multiple (o.d. for 12 days)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years.
• BMI 18 - 27, Weight 50 - 85 kg
• Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start.
• Clinical normal physical findings

Exclusion Criteria

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline
• Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
• Use of any medication (including OTC), herbal preparations, vitamins or nutritional supplements within 2 weeks prior to Visit 2, except for occasional intake of paracetamol (maximum daily dose of 4 g)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

AstraZeneca R&D Lund Sweden

Principal Investigators

Ronnie Beboso

Role: PRINCIPAL_INVESTIGATOR

Chiltern Clinical Research Unit (CCRU).

Locations

Research Site

Slough, Berkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2008-004448-35

Identifier Type: -

Identifier Source: secondary_id

D0570C00005

Identifier Type: -

Identifier Source: org_study_id