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Assess Safety, Tolerability and PK of AZD3199 in Japanese

NCT00772759 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2009-05-05

No results posted yet for this study

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

Interventions

DRUG

AZD3199 Turbuhaler®

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

DRUG

Placebo Turbuhaler®

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

Sponsors & Collaborators

Principal Investigators

  • Ronnie Beboso · Chiltern Clinical Research Unit (CCRU).

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Completion
2009-02-28

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772759 on ClinicalTrials.gov