AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00785915

Purpose

This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects

Condition	Intervention	Phase
Healthy	Drug: AZD6765 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title:	A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments [ Time Frame: During the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine [ Time Frame: During residential period ] [ Designated as safety issue: No ]
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765. [ Time Frame: During the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 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	Drug: AZD6765 single administration and once daily for 5 days
2: Placebo Comparator given (2 subjects in each ethnic/dose group)	Drug: Placebo single administration and once daily for 5 days

Eligibility

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

Criteria

Inclusion Criteria:

Body mass index (BMI): 18 to 27 kg/m 2
Female subjects must be postmenopausal for at least 1 year, surgically sterile, or using a reliable method of contraception at screening.
Male subjects must be willing to use accepted contraceptive methods, avoid unprotected sex, and donating sperm until 3 months after drug administration.

Exclusion Criteria:

Clinically relevant disease and/or abnormalities (past or present)
Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator
Use of any prescription medication within 14 days of Day 1
Use of over-the-counter (OTC) medication (with the exception of acetaminophen), vitamin/nutritional supplements and herbal preparations within 14 days of Day 1
Smoking in excess of 5 cigarettes per day or the equivalent within 28 days of Day 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785915

Contacts

Contact: Parexel International - Baltimore CPRU

410-350-7918

Betsy.GeishenScott@parexel.com

Locations

United States, California
Research Site	Recruiting
GLENDALE, California, United States
United States, Maryland
Research Site	Not yet recruiting
BALTIMORE, Maryland, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Mark Yen, MD

California Clinical Trials

More Information

Responsible Party:	AstraZeneca LP ( United States: Institutional Review Board )
Study ID Numbers:	D6702C00013
Study First Received:	November 3, 2008
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00785915
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

AZD6765
Japanese and Caucasian Healthy Volunteers
Phase I study
Single and multiple Ascending Dose
Japanese volunteers

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009