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

NCT01037725 | Completed Phase 1

• 1 other identifier: D3430C00001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy volunteer; first time in human; food effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

AZD5847 oral suspension

EXPERIMENTAL

Active

Drug: AZD5847

Placebo to AZD5847

PLACEBO COMPARATOR

Placebo

Drug: Placebo to AZD5847

Interventions

AZD5847 DRUG

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

AZD5847 oral suspension

Placebo to AZD5847 DRUG

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

Placebo to AZD5847

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

MeSH Terms

Interventions

posizolid

Study Officials

• Dr. Patricia A Meier, MSc

  Quintiles, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2009
• First Posted: December 23, 2009
• Study Start: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: July 14, 2010

Record last verified: 2010-07

Locations

US (1)