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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:
ClinicalTrials.gov Identifier:
NCT01037725
First Posted: December 23, 2009
Last Update Posted: July 14, 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.
Collaborator:
Quintiles, Inc.
Information provided by:
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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. ]

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. ]
  • 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 ]

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

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 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT01037725


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

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01037725     History of Changes
Other Study ID Numbers: D3430C00001
First Submitted: December 20, 2009
First Posted: December 23, 2009
Last Update Posted: July 14, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Oxazolidinones
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action