AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD6765

Intervention Type DRUG

single administration and once daily for 5 days

2

given (2 subjects in each ethnic/dose group)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

single administration and once daily for 5 days

Interventions

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Placebo

single administration and once daily for 5 days

Intervention Type DRUG

AZD6765

single administration and once daily for 5 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes