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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01116258
First received: April 29, 2010
Last updated: October 8, 2010
Last verified: October 2010
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: 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
  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:
Safety

ClinicalTrials.gov processed this record on July 24, 2014