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Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01037725
First received: December 20, 2009
Last updated: July 13, 2010
Last verified: July 2010
History of Changes
  Purpose

The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics (Including Food Effect) of Ascending Oral Doses of AZD5847 in Healthy Male Subjects and Female Subjects of Non-childbearing Potential

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety and tolerability of AZD5847 administered orally will be assessed by incidence and severity of AE's, abnormalities in vital sign assessments, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals [ Time Frame: Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses. [ Time Frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose. ] [ Designated as safety issue: Yes ]
  • To assess the effect of food on the pharmacokinetics of AZD5847 following oral administration of AZD5847 [ Time Frame: Samples taken during the residential period at defined timepoints pre-dose and post-dose ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: December 2009
Study Completion Date: April 2010
Arms Assigned Interventions
Experimental: AZD5847 oral suspension
Active
 Drug: AZD5847

Part A - Oral doses given to approximately 6 cohorts of 8 subjects (6 on active and 2 on placebo) on Day 1.

Part B - Oral doses of AZD5847 given to 1 cohort of 8 subjects on Days 1 and 8 in either a fasted state or with a high fat meal
Placebo Comparator: Placebo to AZD5847
Placebo
 Drug: Placebo to AZD5847
In Part A - Single oral doses of AZD5847placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) on Day 1

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures
  • Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
  • Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion Criteria:

  • Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
  • History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037725

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Quintiles
Investigators
Principal Investigator: Dr. Patricia A Meier, MSc Quintiles
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01037725     History of Changes
Other Study ID Numbers: D3430C00001
Study First Received: December 20, 2009
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Healthy volunteer
first time in human
food effect

ClinicalTrials.gov processed this record on May 19, 2013