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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01030224
First received: December 9, 2009
Last updated: July 26, 2012
Last verified: March 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD9742
Drug: Placebo to match AZD9742
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9742 IV Infusion
Active
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
Placebo
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)

  Eligibility

Ages Eligible for Study:   23 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030224

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Quintiles
Investigators
Principal Investigator: Dr. Ralph A Schutz Quintiles
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01030224     History of Changes
Other Study ID Numbers: D2690C00001
Study First Received: December 9, 2009
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Healthy volunteer
First time in human

ClinicalTrials.gov processed this record on April 20, 2014