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This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

NCT ID: NCT01030224

Last Updated: 2012-07-27

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

Detailed Description

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Conditions

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Healthy

Keywords

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Healthy volunteer First time in human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AZD9742 IV Infusion

Active

Group Type EXPERIMENTAL

AZD9742

Intervention Type DRUG

Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee

Placebo to AZD9742 IV Infusion

Placebo

Group Type PLACEBO_COMPARATOR

Placebo to match AZD9742

Intervention Type DRUG

Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

Interventions

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AZD9742

Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee

Intervention Type DRUG

Placebo to match AZD9742

Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
* Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion Criteria

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
* History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Minimum Eligible Age

23 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Ralph A Schutz

Role: PRINCIPAL_INVESTIGATOR

Quintiles, Inc.

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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D2690C00001

Identifier Type: -

Identifier Source: org_study_id