JSAD/JMAD: AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00785915

Collaborator

(none)

Enrollment

Locations

Arms

3.9

Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: AZD6765 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: AZD6765 single administration and once daily for 5 days
Placebo Comparator: 2 given (2 subjects in each ethnic/dose group)	Drug: Placebo single administration and once daily for 5 days

Arm

Intervention/Treatment

Experimental: 1

Drug: AZD6765

single administration and once daily for 5 days

Placebo Comparator: 2

given (2 subjects in each ethnic/dose group)

Drug: Placebo

single administration and once daily for 5 days

Outcome Measures

Primary Outcome Measures

Safety and tolerability; Adverse events (AEs), vital signs, physical examinations, ECGs and clinical laboratory assessments [During the study]

Secondary Outcome Measures

Pharmacokinetic - Pharmacokinetic parameters for AZD6765 in plasma and urine [During residential period]
Genetics; Collect blood samples for optional exploratory genetic studies focusing on identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6765. [During the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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