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Assess Safety, Tolerability and PK of AZD3199 in Japanese

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00772759
First received: October 14, 2008
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: AZD3199 Turbuhaler®
Drug: Placebo Turbuhaler®
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Single and Multiple Ascending Doses of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Japanese Healthy Men

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic Parameters derived from plasma concentration and optionally urinary excretion of AZD3199. [ Time Frame: During residential period ] [ Designated as safety issue: No ]
  • Pharmacodynamic Potassium and lactate concentrations, tremor and palpitations, heart rate, QTc, pulse rate, blood pressure, and forced expiratory volume in one second (FEV1). [ Time Frame: During residential period ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2008
Study Completion Date: February 2009
Arms Assigned Interventions
Experimental: 1
Dry powder for oral inhalation
Drug: AZD3199 Turbuhaler®
240, 720 and 2160 μ g, single and multiple (o.d. for 12 days)
Placebo Comparator: 2
Dry powder for oral inhalation
Drug: Placebo Turbuhaler®
single and multiple (o.d. for 12 days)

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772759

Locations
United Kingdom
Research Site
Slough, Berkshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Ronnie Beboso Chiltern Clinical Research Unit (CCRU).
  More Information

No publications provided

Responsible Party: Lars Grundemar, MD, Medical Science Director, AstraZeneca R&D Lund Sweden
ClinicalTrials.gov Identifier: NCT00772759     History of Changes
Other Study ID Numbers: D0570C00005, 2008-004448-35
Study First Received: October 14, 2008
Last Updated: May 4, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
AZD3199
Japanese Healthy Volunteers
Phase I study
Single and Multiple Ascending Dose
safety
tolerability
PK

ClinicalTrials.gov processed this record on November 20, 2014