Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Doses of AZD2066 in Japanese Subjects - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00766012

Purpose

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.

Condition	Intervention	Phase
Healthy	Drug: AZD2066 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Phase I, Single-Centre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Oral Doses of AZD2066 in Japanese Healthy Male Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability by assessment of vital signs, laboratory variables and ECG [ Time Frame: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Investigate pharmacokinetic profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 in Japanese healthy male subjects [ Time Frame: Blood sampling at defined timepoints during residential period and follow-up ] [ Designated as safety issue: No ]
Investigate CNS effects of AZD2066 in Japanese healthy male subjects [ Time Frame: Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes. ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2008
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4 dose panels receiving a specified volume of AZD2066 oral solution once daily for 11 days	Drug: AZD2066 Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels. Specific dose depends on dose panel.
2: Placebo Comparator Included in each dose panel	Drug: Placebo Oral solution administered orally once per day on day 1, and then day 3 through to day 12 for the first and second dose panels and day 5 through to day 14 for the third and fourth dose panels.

Eligibility

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

Criteria

Inclusion Criteria:

Provision of signed informed consent
Healthy Japanese males as judged by the investigator
Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.

Exclusion Criteria:

History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
Intake of medicine (except occasional paracetamol) within first 2 weeks before first administration of study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766012

Contacts

Contact: AstraZeneca Japan Clinical Study Information

+81-6-6453-8011

Locations

Japan
Research SIte	Recruiting
FUKUOKA, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Rolf Karlsten	AstraZeneca R&D Södertälje, Sweden
Principal Investigator:	Shin Irie	Kyusyu Clinical Phramacology Research Clinic

More Information

Responsible Party:	AstraZeneca ( Rolf Karlsten, MD, PhD, Medical Science Director )
Study ID Numbers:	D0475C00004
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00766012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

safety
tolerability
pharmacokinetics
AZD2066
Japanese

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009