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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 29, 2010
Last updated: October 8, 2010
Last verified: October 2010

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
Drug: AZD5847
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, 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) ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116258

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

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01116258     History of Changes
Other Study ID Numbers: D3430C00002
Study First Received: April 29, 2010
Last Updated: October 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:

ClinicalTrials.gov processed this record on April 17, 2014