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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030224
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : July 27, 2012
Quintiles, Inc.
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD9742 Drug: Placebo to match AZD9742 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: AZD9742 IV Infusion
Drug: 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

Placebo Comparator: Placebo to AZD9742 IV Infusion
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)

Primary Outcome Measures :
  1. Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals [ Time Frame: Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events. ]

Secondary Outcome Measures :
  1. Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine [ Time Frame: Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030224

United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Quintiles, Inc.
Principal Investigator: Dr. Ralph A Schutz Quintiles, Inc.

Responsible Party: AstraZeneca Identifier: NCT01030224     History of Changes
Other Study ID Numbers: D2690C00001
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: March 2010

Keywords provided by AstraZeneca:
Healthy volunteer
First time in human