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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014