A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01064388
First received: February 3, 2010
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single Center, Double-blind Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) [ Time Frame: collected prior to treatment, during treatment and follow-up for a total of 25-30 days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the Pharmacokinetics of AZD9742 in blood and urine [ Time Frame: PK-sampling during 14 pre-defined study days for PK profiling ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD9742
IV infusion, 15 days
Placebo Comparator: 2 Drug: Placebo
IV infusion, 15 days

  Eligibility

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

Inclusion Criteria:

  • BMI between 19-30

Exclusion Criteria:

  • Positive Fecal Occult Blood Test
  • Prescriptions that inhibit liver function
  • Received flu/H1N1 vaccine within 2 weeks before first dose
  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: NCT01064388

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Andrew Shaw AstraZeneca
Study Chair: Brendan Smyth AstraZeneca
Study Director: David Melnick AstraZeneca
Principal Investigator: Ralph Schutz Quintiles
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01064388     History of Changes
Other Study ID Numbers: D2690C00002
Study First Received: February 3, 2010
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Safety

ClinicalTrials.gov processed this record on September 14, 2014