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Trial record 3 of 3 for:    AZD5847

A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01116258
First Posted: May 4, 2010
Last Update Posted: October 11, 2010
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.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Condition Intervention Phase
Healthy Drug: AZD5847 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential

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 to 52 days(includes upto 28 days for screening) ]

Secondary Outcome Measures:
  • characterize the Pharmacokinetics of AZD9742 in blood and urine [ Time Frame: PK-sampling during 14 pre-defined study days for PK profiling ]

Estimated Enrollment: 60
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD5847
oral suspension, 15 days
Placebo Comparator: 2 Drug: Placebo
oral suspension, 15 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI between 18-30

Exclusion Criteria:

  • Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
  • History of presence of gastrointestinal, hepatic or renal disease
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01116258


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: Eleanor Lisbon Quintiles, Inc.
  More Information

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01116258     History of Changes
Other Study ID Numbers: D3430C00002
First Submitted: April 29, 2010
First Posted: May 4, 2010
Last Update Posted: October 11, 2010
Last Verified: October 2010

Keywords provided by AstraZeneca:
Safety