Single and Multiple Ascending Doses of AZD1981 in Japan - Full Text View

Purpose

The purpose of this study is to study safety, tolerability and pharmacokinetics of AZD1981 in healthy Japanese subjects

Condition	Intervention	Phase
Healthy	Drug: AZD1981 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety Study

Official Title:	A Randomised, Placebo-Controlled, Double-Blind, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of AZD1981 in Healthy Male Japanese and Caucasian Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Adverse events [ Time Frame: All the time ] [ Designated as safety issue: No ]
Plasma drug concentration [ Time Frame: Every hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical chemistry [ Time Frame: day 1 and 9 ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: AZD1981 Oral tablet, 250 mg single dose
2: Experimental	Drug: AZD1981 Suspension, 15, 75, 1000 and 2000 mg
3: Placebo Comparator	Drug: Placebo

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698282

Contacts


Contact: Eva Pettersson	46-46-336-140	eva.pettersson@astrazeneca.com

Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Elizabeth Hancox	Europe Chiltern International Ltd, Berkshire, UK

More Information

Responsible Party:	AstraZeneca Pharmaceuticals ( Christer Hultquist, MD, Medical Science Director, R&D )
Study ID Numbers:	D9831C00005
First Received:	June 16, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00698282
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00698282