Assess Safety, Tolerability and PK of AZD3199 in Japanese

NCT00772759 | Completed Phase 1 DMC

• 2 other identifiers: D0570C000052008-004448-35
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

AZD3199; Japanese Healthy Volunteers; Phase I study; Single and Multiple Ascending Dose; safety; tolerability; PK

Outcome Measures

Primary Outcomes (1)

• Safety/Tolerability - 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)

  During the study

Secondary Outcomes (2)

• Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199.

  During residential period

• Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1).

  During residential period

Study Arms (2)

1

EXPERIMENTAL

Dry powder for oral inhalation

Drug: AZD3199 Turbuhaler®

2

PLACEBO COMPARATOR

Dry powder for oral inhalation

Drug: Placebo Turbuhaler®

Interventions

AZD3199 Turbuhaler® DRUG

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

1

Placebo Turbuhaler® DRUG

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

2

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Slough, Berkshire, United Kingdom

Location

Study Officials

• Ronnie Beboso

  Chiltern Clinical Research Unit (CCRU).

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 15, 2008
• Study Start: October 1, 2008
• Study Completion: February 1, 2009
• Last Updated: May 5, 2009

Record last verified: 2009-05

Locations

GB (1)