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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD5847; Drug: Placebo to AZD5847

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Safety assessments are taken prior to and after drug administration. Volunteers will be monitored througout the study for adverse events.

Secondary Outcome Measures

Outcome Measure	Time Frame
To characterize the pharmacokinetics of AZD5847 in blood and urine following oral doses.	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	Samples taken during the residential period at defined timepoints pre-dose and post-dose

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Quintiles, Inc.
• Investigators: Principal Investigator: Dr. Patricia A Meier, MSc, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: December 20, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 14, 2010
• Last Update Submitted That Met QC Criteria: July 13, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: first time in human; food effect; Healthy volunteer
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Protein Synthesis Inhibitors; Oxazolidinones
• Other Study ID Numbers: D3430C00001