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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

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. Identifier: NCT01116258
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : October 11, 2010
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Brief Summary:
The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Condition or disease Intervention/treatment Phase
Healthy Drug: AZD5847 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: 1 Drug: AZD5847
oral suspension, 15 days

Placebo Comparator: 2 Drug: Placebo
oral suspension, 15 days

Primary Outcome Measures :
  1. 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 :
  1. characterize the Pharmacokinetics of AZD9742 in blood and urine [ Time Frame: PK-sampling during 14 pre-defined study days for PK profiling ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01116258

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United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
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Study Director: Andrew Shaw AstraZeneca
Study Chair: Brendan Smyth AstraZeneca
Study Director: David Melnick AstraZeneca
Principal Investigator: Eleanor Lisbon Quintiles, Inc.
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Responsible Party: MSD, AstraZeneca Identifier: NCT01116258    
Other Study ID Numbers: D3430C00002
First Posted: May 4, 2010    Key Record Dates
Last Update Posted: October 11, 2010
Last Verified: October 2010
Keywords provided by AstraZeneca: