AZD9742 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese 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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-07-31

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 AZD9742 in healthy male and female Japanese 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

Dose level A, B, C and optional Dose level D and E: single administration and one to three times daily for 6 days (Japanese n=8)

Group Type EXPERIMENTAL

AZD9742

Intervention Type DRUG

IV Formulation

2

placebo given (2 subjects in each dose group)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV Formulation

Interventions

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AZD9742

IV Formulation

Intervention Type DRUG

Placebo

IV Formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female (non-childbearing potential)
* Body mass index (BMI) : 17 to 27 kg/m 2

Exclusion Criteria

* History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic, or renal disease or any otherHistory or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Minimum Eligible Age

23 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes