Single and Multiple Ascending Doses of AZD1981 in Japan (JSAD/JMAD)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00698282
First received: June 16, 2008
Last updated: November 30, 2010
Last verified: November 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 ]

Enrollment: 47
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD1981
Oral tablet, 250 mg single dose
Experimental: 2 Drug: AZD1981
Suspension, 15, 75, 1000 and 2000 mg
Placebo Comparator: 3 Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Japanese and Caucasian males

Exclusion Criteria:

  • Other clinically relevant disease or disorders
  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: NCT00698282

Locations
United Kingdom
Research Site
Berkshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Elizabeth Hancox Europe Chiltern International Ltd, Berkshire, UK
  More Information

No publications provided

Responsible Party: Christer Hultquist, MD, Medical Science Director, R&D, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00698282     History of Changes
Other Study ID Numbers: D9831C00005
Study First Received: June 16, 2008
Last Updated: November 30, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 16, 2014