This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects
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
1 other identifier
interventional
48
1 country
1
Brief Summary
The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 9, 2009
CompletedFirst Posted
Study publicly available on registry
December 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJuly 27, 2012
March 1, 2010
4 months
December 9, 2009
July 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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 Outcomes (1)
Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine
Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.
Study Arms (2)
AZD9742 IV Infusion
EXPERIMENTALActive
Placebo to AZD9742 IV Infusion
PLACEBO COMPARATORPlacebo
Interventions
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
Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Quintiles, Inc.collaborator
Study Sites (1)
Research Site
Overland Park, Kansas, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Ralph A Schutz
Quintiles, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2009
First Posted
December 11, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
July 27, 2012
Record last verified: 2010-03